Impact of body mass index on the development of pocket hematoma: A retrospective study in Chinese people

BackgroundPocket hematoma is one of the major complications associated with cardiovascular implantable electronic devices （CIEDs） implantation. The aim of this study is to evaluate the impact of body mass index （BMI） on the occurrence of pocket hematoma after CIEDs implantation.MethodsThe study is a retrospective review of 972 patients receiving CIEDs implantation between 2008 and 2012 in a tertiary hospital.ResultsTwenty two patients （2.2%） developed severe pocket hematoma requiring re-intervention. The hematoma rate （4.6%,n = 15） of patients with a BMI of 〈 23 kg/m2 was significantly higher compared with that of patients with a BMI of≥23 kg/m2 （1.1%, n = 7,P〈 0.001）. In multivariate regression analysis, a BMI 〈 23.0 kg/m2 may be associated with the development of severe pocket hema-toma. An increase of 1.0 kg/m2 in BMI was associated with lower incidence of hematoma formation （OR： 0.84; 95% CI： 0.74-0.95;P = 0.006）.ConclusionBMI 〈 23 kg/m2 was associated with a higher incidence of pocket hematoma, requiring re-intervention. The data sup-port that great care must be taken when patients were with a lower BMI received CIEDs implantation.     

Extent of weight reduction necessary for minimization of diabetes risk in Japanese men with visceral fat accumulation and glycated hemoglobin of 5.6–6.4%

Aims/Introduction

Weight reduction improves glycemic control in obese men with glycated hemoglobin (HbA1c) of 5.6–6.4%, suggesting that it can prevent the development of diabetes in these patients. The aim of the present study was to quantify the amount of weight reduction necessary for minimization of diabetes risk in Japanese men with visceral fat accumulation.

Materials and Methods

The study participants were 482 men with an estimated visceral fat area of ≥100 cm², HbA1c of 5.6–6.4%, fasting plasma glucose (FPG) of <126 mg/dL or casual plasma glucose <200 mg/dL. They were divided into two groups based on weight change at the end of the 3-year follow-up period (weight gain and weight loss groups). The weight loss group was classified into quartile subgroups (lowest group, 0 to <1.2%: second lowest group, ≥1.2 to <2.5%: second highest group, ≥2.5 to <4.3%: highest group, ≥4.3% weight loss). The development of diabetes at the end-point represented a rise in HbA1c to ≥6.5% or FPG ≥126 mg/dL, or casual plasma glucose ≥200 mg/dL.

Results

The cumulative incidence of diabetes at the end of the 3-year follow-up period was 16.2% in the weight gain group and 10.1% in the weight loss group (P not significant). The incidence of diabetes was significantly lower in the highest weight loss group (3.1%), but not in the second highest, the second lowest and the lowest weight loss groups (9.7, 10.1 and 18.3%), compared with the weight gain group.

Conclusions

Minimization of the risk of diabetes in Japanese men with visceral fat accumulation requires a minimum of 4–5% weight loss in those with HbA1c of 5.6–6.4%.     

The prevalence and clinical impact of obesity in adults with Marfan syndrome

BACKGROUND:

Patients with Marfan syndrome characteristically have an asthenic body habitus and are considered to be exempt from the obesity epidemic.

OBJECTIVE:

To examine the prevalence and clinical impact of obesity in a cohort of adults with Marfan syndrome.

METHODS:

Fifty outpatients (30 female) with a mean (± SD) age of 38±13 years were studied. Demographic variables including previously identified risk factors for aortic dissection were recorded. Body mass index (BMI) was determined and patients were classified as normal (BMI less than 25 kg/m²), overweight (BMI 25 kg/m² to 29.9 kg/m²) or obese (BMI 30 kg/m² or greater). Other cardiovascular risk factors were examined. An adverse clinical outcome was defined as either the attainment of surgical criteria for aortic root replacement or the presence of aortic dissection.

RESULTS:

A family history of aortic dissection was present in 13 (26%) patients. In 23 (46%) patients, there was no known family history of Marfan syndrome. Mean BMI was 25.4±7.4 kg/m², with 18 (36%) patients having an elevated BMI. Positive smoking status was present in 15 (30%), hypertension in 13 (26%) and hyperlipidemia in 19 (38%) patients. Adverse clinical outcome was present in 27 (54%) patients. Logistic regression analysis revealed only index case (OR 44; P<0.001) and higher BMI (OR 1.2; P=0.04) to be significantly and independently associated with increased risk of adverse clinical outcome.

CONCLUSIONS:

Obesity is common in adults with Marfan syndrome and is associated with an increased risk of aortic complications.     

Prevalence and clinical profile of metabolic obesity and phenotypic obesity in Asian Indians

Background

We estimated the prevalence of metabolically obese nonobese (MONO), metabolically obese obese (MOO), and metabolically healthy obese (MHO) individuals and correlated this with the prevalence of coronary artery disease (CAD) compared to metabolically healthy nonobese (MHNO) in urban South Indians.

Method

Study subjects (n = 2350) were recruited from the Chennai Urban Rural Epidemiology Study. Generalized obesity was defined as a body mass index (BMI) ≥25 kg/m², based on the World Health Organization Asia Pacific guidelines. Metabolic syndrome (MS) was diagnosed based on the South Asian Modified-National Cholesterol Education Programme criteria. Coronary artery disease was defined by known myocardial infarction or Q waves on resting electrocardiogram.

Results

Metabolically obese nonobese was defined as nonobese subjects (BMI < 25 kg/m²) with MS, MOO as obesity (BMI ≥ 25 kg/m²) with MS, MHO as obese subjects (BMI ≥ 25 kg/m²) with no MS, and MHNO as no obesity or MS. Metabolically obese nonobese was identified in 355 (15.1%), MOO in 348 (14.8%), MHO in 312 (13.3%), and MHNO in 1335 (56.8%) subjects. The prevalence of CAD among the MONO, MOO, MHO, and MHNO was 5.5%, 4.2%, 1.4%, and 2.6%. However, when age standardization was done, there was no statistically significant increase in the risk of CAD among MONO [odds ratio (OR) = 1.300, 95% confidence interval (CI) 0.706–2.394, p = .339], MOO (OR = 1.651, 95% CI 0.852–3.199, p = .137), and MHO (OR = 0.524, 95% CI 0.250–2.130, p = .564) groups compared to MHNO, perhaps due to small numbers.

Conclusion

Metabolic obesity may have different clinical implications than phenotypic obesity.     

Obesity as an effect modifier of the association between leptin and diabetic kidney disease

Aims/Introduction

Obesity has been shown to be a modifier of the association between leptin levels and cardiovascular events. We examined whether obesity modifies the association between serum leptin levels and the progression of diabetic kidney disease.

Materials and Methods

This was an observational longitudinal study on patients with type 2 diabetes. We enrolled 410 and 348 patients in the eGFR and ACR cohorts, respectively. Patients were classified into three groups by sex‐specific tertile of leptin levels. Obesity was defined as body mass index ≥25 kg/m². Outcomes were the rate of change in estimated glomerular filtration rate (eGFR) and progression to a more advanced stage of albuminuria.

Results

In the eGFR cohort, the mean eGFR change during the median follow‐up period of 4.7 years was −1.4 mL/min/1.73 m²/year. An interaction between leptin levels (low, medium or high) and obesity (present or absent) on the change in eGFR was detected (P interaction = 0.003). In the lean group, adjusted eGFR decline in patients with low leptin was steeper than that in patients with medium leptin (2.1 and 0.8 mL/min/1.73 m²/year, P = 0.023). In the obese group, patients with high leptin had a steeper adjusted eGFR decline than those with medium leptin (1.7 and 0.6 mL/min/1.73 m²/year, P = 0.044). In the ACR cohort, 29 patients showed progression of albuminuria during the median follow‐up period of 3.9 years. There was no interaction between leptin levels and obesity on the outcome (P interaction = 0.094).

Conclusions

Obesity might modify the effects of leptin on kidney function decline in patients with type 2 diabetes.     

Meaning of upper limit of normal range of post‐load 1‐h plasma glucose level defined by oral glucose tolerance test in Japanese subjects

Aims/Introduction

To identify upper limit post‐load 1‐h plasma glucose (1‐h PG) after 75‐g oral glucose test in a Japanese population.

Materials and Methods

A total of 918 subjects were enrolled. We divided the subjects into two groups: normal 2‐h post‐load plasma glucose (2‐h PG; <140 mg/dL) and impaired 2‐h PG group (≥140 mg/dL).

Results

A total of 417 subjects had normal 2‐h PG and 501 had impaired 2‐h PG. The receiver operating characteristic (ROC) curve showed that the optimal cut‐off value of 1‐h PG was 179 mg/dL (area under ROC curve = 0.89), providing that the sensitivity, specificity, and positive and negative predictive value were 85, 79, 82 and 83%, respectively. The subjects with 1‐h PG < 179 mg/dL consisted of 0.5% diabetes and 99.5% non‐diabetes, whereas those with 1‐h PG ≥ 179 mg/dL consisted of 26.9% diabetes and 73.1% non‐diabetes (P < 0.01). Furthermore, there was a significant correlation between 1‐h PG and 2‐h PG (r² = 0.57, P < 0.01).

Conclusions

These data suggested that 179 mg/dL is the upper limit of the normal range of post‐load of 1‐h PG in a Japanese population. Thus, the subjects with 1‐h PG ≥ 179 mg/dL might be at risk of developing future diabetes. Therefore, appropriate prospective study should be carried out to test this hypothesis.     

Diabetes and Prior Coronary Heart Disease are Not Necessarily Risk Equivalent for Future Coronary Heart Disease Events

Background

For more than a decade, the presence of diabetes has been considered a coronary heart disease (CHD) “risk equivalent”.

Objective

The objective of this study was to revisit the concept of risk equivalence by comparing the risk of subsequent CHD events among individuals with or without history of diabetes or CHD in a large contemporary real-world cohort over a period of 10 years (2002 to 2011).

Design

Population-based prospective cohort analysis.

Participants

We studied a cohort of 1,586,061 adult members (ages 30–90 years) of Kaiser Permanente Northern California, an integrated health care delivery system.

Main Measurements

We calculated hazard ratios (HRs) from Cox proportional hazard models for CHD among four fixed cohorts, defined by prevalent (baseline) risk group: no history of diabetes or CHD (None), prior CHD alone (CHD), diabetes alone (DM), and diabetes and prior CHD (DM + CHD).

Key Results

We observed 80,012 new CHD events over the follow-up period (~10,980,800 person-years). After multivariable adjustment, the HRs (reference: None) for new CHD events were as follows: CHD alone, 2.8 (95 % CI, 2.7–2.85); DM alone 1.7 (95 % CI, 1.66–1.74); DM + CHD, 3.9 (95 % CI, 3.8–4.0). Individuals with diabetes alone had significantly lower risk of CHD across all age and sex strata compared to those with CHD alone (12.2 versus 22.5 per 1000 person-years). The risk of future CHD for patients with a history of either DM or CHD was similar only among those with diabetes of long duration (≥10 years).

Conclusions

Not all individuals with diabetes should be unconditionally assumed to be a risk equivalent of those with prior CHD.KEY WORDS: coronary heart disease, diabetes, epidemiology     

The relationship between the frequency of self‐monitoring of blood glucose and glycemic control in patients with type 1 diabetes mellitus on continuous subcutaneous insulin infusion or on multiple daily injections

Aims/Introduction

We investigated the relationship between the frequency of self-monitoring of blood glucose (SMBG) and glycemic control in type 1 diabetes mellitus patients on continuous subcutaneous insulin infusion (CSII) or on multiple daily injections (MDI) using data management software.

Materials and Methods

We recruited 148 adult type 1 diabetes mellitus patients (CSII n = 42, MDI n = 106) and downloaded their SMBG records to the MEQNET™ SMBG Viewer software (Arkray Inc., Kyoto, Japan). The association between the SMBG frequency and the patients'' hemoglobin A1c (HbA1c) levels was analyzed using the χ²-test and linear regression analysis was carried out to clarify their relationship.

Results

The odds ratio of achieving a target HbA1c level of <8% (63.9 mmol/mol) was significantly higher in subjects with SMBG frequencies of ≥3.5 times/day compared with those with SMBG frequencies of <3.5 times/day in the CSII group (odds ratio 7.00, 95% confidence interval 1.72–28.54), but not in the MDI group (odds ratio 1.35, 95% CI 0.62–2.93). A significant correlation between SMBG frequency and the HbA1c level was detected in the CSII group (HbA1c [%] = –0.24 × SMBG frequency [times/day] + 8.60 [HbA1c {mmol/L} = –2.61 × SMBG frequency {times/day} + 70.5], [r = –0.384, P = 0.012]), but not in the MDI group.

Conclusions

A SMBG frequency of <3.5 times per day appeared to be a risk factor for poor glycemic control (HbA1c ≥8%) in type 1 diabetes mellitus patients on CSII.     

Predictability of 1‐h postload plasma glucose concentration: A 10‐year retrospective cohort study

Aims/Introduction

Elevated 1-h postload plasma glucose concentration (1hPG) during oral glucose tolerance test has been linked to an increased risk of type 2 diabetes and a poorer cardiometabolic risk profile. The present study analyzed the predictability and cut-off point of 1hPG in predicting type 2 diabetes in normal glucose regulation (NGR) subjects, and evaluated the long-term prognosis of NGR subjects with elevated 1hPG in glucose metabolism, kidney function, metabolic states and atherosclerosis.

Materials and Methods

A total of 116 Han Chinese classified as NGR in 2002 at the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China, were investigated. Follow-up was carried out in 2012 to evaluate the progression of glucose metabolism, kidney function, metabolic syndrome and carotid atherosclerosis.

Results

The areas under receiver operating characteristic curves were higher for 1hPG than FPG or 2hPG (0.858 vs 0.806 vs 0.746). The cut-off value of 1hPG with the maximal sum of sensitivity and specificity in predicting type 2 diabetes in NGR subjects was 8.85 mmol/L. The accumulative incidence of type 2 diabetes in subjects with 1hPG ≥8.85 mmol/L was higher than those <8.85 mmol/L (46.2% vs 3.3%, P = 0.000; relative risk 13.846, 95% confidence interval 4.223–45.400). On follow up, the prevalence of metabolic syndrome and abnormal carotid intima-media thickness in the subjects with 1hPG ≥8.85 mmol/L tended to be higher compared with those <8.85 mmol/L.

Conclusions

1hPG is a good predictor of type 2 diabetes in NGR subjects, and the best cut-off point is 8.85 mmol/L. Some tendency indicates that NGR subjects with 1hPG ≥8.85 mmol/L are more prone to metabolic syndrome and carotid atherosclerosis.     

Assessment of glycemic control in patients with type 2 diabetes mellitus treated with metformin–sulfonylurea combination: Results of a multicenter,cross‐sectional,observational study in Korea

Aims/Introduction

To assess the current status of glycemic control in patients with type 2 diabetes treated with a combination of metformin and sulfonylurea for >3 months, as measured by glycosylated hemoglobin (HbA1c).

Materials and Methods

Data on patient demographics, diabetic complications, HbA1c, fasting plasma glucose (FPG) and type of treatment were collected in this multicenter, cross-sectional, non-interventional study.

Results

From April 2008 to February 2009, 5,628 patients were recruited from 299 centers in Korea. Patients characteristics (mean ± SD) were as follows: age 58.4 ± 10.8 years, duration of diabetes 6.1 ± 4.7 years, body mass index 24.7 ± 2.9 kg/m², HbA1c 7.77 ± 1.22%, FBG 147.4 ± 46.5 mmol/L and FPG 164.0 ± 54.3 mmol/L. The most common diabetic complication was neuropathy (22.5%), followed by retinopathy (18.3%) and microalbuminuria (16.1%). Just 1,524 (27.1%) patients achieved HbA1c ≤7%. A higher number of patients (32.6%) treated by endocrinologists achieved HbA1c ≤7% than those treated by internists (24.4%) and primary care physicians (23.2%). In multivariate analyses, diabetic retinopathy (odds ratio 0.455, 95% confidence interval 0.341–0.606), nephropathy (odds ratio 0.639, 95% confidence interval 0.43–0.949), diabetes for ≥5 years (odds ratio 0.493, 95% confidence interval 0.4–0.606) and older age added by 1 year (odds ratio 1.019, 95% confidence interval 1.01–1.029) was significantly associated with achieving target HbA1c. In addition, treatment by endocrinologists rather than internists significantly increased chances of achieving target HbA1c (odds ratio 1.417, 95% confidence interval 1.146–1.751).

Conclusions

The majority of patients with type 2 diabetes in Korea had inadequate glycemic control, despite receiving a combination of metformin and sulfonylurea.     

Pilot study for the evaluation of morphological and functional changes in retinal blood flow in patients with insulin resistance and/or type 2 diabetes mellitus

Background

The aim of this study was to investigate early morphological and functional pathology in the retinal micro-circulation in patients with insulin resistance and/or type 2 diabetes mellitus (T2DM).

Methods

Fifty-four subjects, without features of retinopathy under ophthalmological investigation, were recruited for study participation and were classified into three study groups according to their metabolic staging: (1) Group C comprised nondiabetic, insulin-sensitive subjects with a BMI <28kg/m²; (2) Group IR comprised nondiabetic, insulin-resistant, obese subjects with a BMI ≥28 kg/m²; and (3) Group DM comprised patients with manifested T2DM.Retinal microvascular blood flow was assessed using scanning laser doppler flowmetry (Heidelberg Retina Flowmeter) before and after flicker light stimulation (10 Hz; Photo Stimulater 750).

Results

No significant difference was observed in retinal blood flow (RBF) among the three groups, neither at baseline nor after stimulating the retina with flicker light. The arterial wall-to-lumen ratio (WLR) tended to be smaller in Group DM compared with Group C, and was significantly lower when comparing Group IR with Group C. When the subjects were grouped according to their insulin resistance, a steady decline in RBF and WLR could be observed with increasing insulin resistance.

Conclusions

In conclusion, laser scanner flowmetry of the retina was found to detect very early changes in microvascular blood flow. Development of insulin resistance seems to be an important component in the deterioration of RBF.     

BMI Change Patterns and Disability Development of Middle-aged Adults with Diabetes: A Dual Trajectory Modeling Approach

BACKGROUND

Few longitudinal studies have examined associations between body mass index (BMI) changes in adults with diabetes and the development of disability.

OBJECTIVE

To investigate association patterns between BMI and disability in middle-aged adults with diabetes.

DESIGN AND SETTING

Retrospective cohort design with data from the 1992–2006 Health and Retirement Study (HRS). A group-based joint trajectory method identified distinct BMI change trajectories and their link to subsequent disability trajectories.

PARTICIPANTS

U.S. nationally representative adults aged 51–61 who reported a diagnosis of diabetes in the 1992 HRS (N = 1,064).

MEASUREMENTS

BMI and self-reported disability score were the main variables. Sociodemographic, clinical, behavioral, and diabetes-related factors were also examined.

RESULTS

Four distinct weight trajectories (stable normal weight, 28.7 %; stable overweight, 46.2 %; loss and regain obese, 18.0 %; weight cumulating morbidly obese, 7.1 %) and three disability trajectories (little or low increase, 34.4 %; moderate increase, 45.4 %; chronic high increase, 20.2 %) best characterized the long-term patterns of BMI and disability change in middle-aged adults with diabetes. Adults in stable normal weight had the highest probability of being in the little/low increase disability group; however, one in five adults in that group progressed into chronic high disability, a higher proportion compared to the stable overweight group.

CONCLUSIONS

Although there were various ways in which the two trajectories were linked, the beneficial impacts of optimizing weight in adults with diabetes were supported. In addition, the complexity of diabetes control in those with relatively normal weight was highlighted from this study.

Electronic supplementary material

The online version of this article (doi:10.1007/s11606-013-2399-z) contains supplementary material, which is available to authorized users.KEY WORDS: weight, physical function, diabetes, group-based modelingOverweight and obesity, defined by body mass index (BMI, kg/m2) of 25.0–29.9 and 30.0 and above, respectively,¹ is common in adults with diabetes. Despite acknowledged difficulties with losing weight and maintaining weight loss, current clinical practice guidelines for diabetes and diabetes researchers continue to emphasize the importance of weight management in adults with diabetes.Research in clinical and community settings has examined general weight change patterns in adults living with diabetes over time, yielding inconsistent findings^2–7 and suggesting that the longitudinal course of body weight in middle-aged and older adults with diabetes exhibits not only intra-individual but also inter-individual variation.Only recently have researchers begun to more explicitly examine distinct weight trajectories in adults with diabetes.^8,9 However, these studies are limited by relatively short periods of follow-up (1 and 3 years, respectively); thus, weight fluctuations¹⁰ may not be well-detected. In addition, use of medical records rather than population-based data may not capture variations in demographically and geographically heterogeneous adults with diabetes. Further, few studies have investigated how weight changes longitudinally in relation to the development of disability, a key determinant of quality of life in adults with diabetes. In one study of adults (not limited to those with diabetes), Kahng and colleagues¹¹ found that although obesity was associated with more functional disability in cross-sectional analyses, change in BMI was not related to change in physical function over time. We argue that the simultaneous measure of BMI and disability in their study may have obscured the real (or lagged) association between change in BMI and change in disability. In another study that examined the lagged effect of BMI on disability, Ferraro and colleagues¹² found that disability risk was higher for obese persons, but that overweight was not consistently associated with higher disability. Whether this pattern exists in adults living with diabetes is not yet known.The current study aimed to fill these gaps by examining longitudinal data on BMI and disability in a representative sample of U.S. adults aged 51–61 diagnosed with diabetes. We use a dual trajectory model within a group-based trajectory modeling approach (a.k.a., latent class growth model [LCGM])^13–15 to evaluate 10-year weight trajectory patterns from 1992 to 2002 and the patterns’ associations with disability trajectories in years 10 to 14 (2002–2006). Three research questions were posed: (1) What are the main patterns of weight and disability trajectories experienced by middle-aged and older adults living with diabetes?; (2) What is the proportion of each trajectory in the population?; and (3) How are weight trajectories associated with disability trajectories later in life, as well as baseline sociodemographic, clinical, behavioral, and diabetes-related factors?     

Impact of a physician-supervised exercise-nutrition program with testosterone substitution in partial androgen-deficient middle-aged obese men

Background Partial androgen deficiency syndrome in the aging male is associated with signs of aging such as a development of abdominal obesity, sexual dysfunction, increase body fat, weight gain and the development of cardiac disease. Objective We assessed the outcome of a commercially available physician supervised nutrition and exercise program with concomitant testosterone replacement therapy in middle age obese men with partial androgen deficiency in order to reduce cardiac risks factors. Methods Fifty-six self referred men without diabetes mellitus, hypertension, or cardiovascular disease (ages 52.3 ± 7.8 years) were randomly selected from a large cohort. Baseline weight, body fat composition, fasting glucose, hemoglobin A1c and fasting lipid levels, as well as free and total testosterone levels were assessed. All patients were assessed and followed 6–18 months after initiation of the program. The program consisted of a low glycemic load balanced nutrition diet, a recommended structured daily exercise program of 30–60 minutes, as well as once to twice weekly intramuscular testosterone injections (113.0 ± 27.8 mg). Results At follow up, weight was reduced from 233.9 ± 30.0 pounds (lbs) to 221.3 ± 25.1 lbs (P < 0.001), BMI was reduced from 33.2 ± 3.3 kg/m² to 31.3 ± 2.8 kg/m² (P < 0.0001). Total body fat was 27.1% ± 5.2% vs. 34.3% ± 5.7% at baseline (P < 0.0001). Fasting glucose was reduced from 95.3 ± 14.4 mg/dL to 87.5 ± 12.6 mg/dL (P < 0.0001). Total cholesterol was reduced from 195.4 ± 33.0 mg/dL to 172.7 ± 35.0 mg/dL (P < 0.005). No clinically significant adverse events were recorded. Conclusions Testosterone replacement therapy in middle aged obese men with partial androgen deficiency appeared safe and might have promoted the effects of a weight reduction diet and daily exercise program as long as an adequate physician supervision and follow up was granted. The combination therapy significantly reduced coronary risk factors such as glucose intolerance and hyperlipidemia.     

Electronic Tools to Assist with Identification and Counseling for Overweight Patients: a Randomized Controlled Trial

Background

Physicians often do not recognize when their patients are overweight and infrequently counsel them about weight loss.

Objective

To evaluate a set of electronic health record (EHR)-embedded tools to assist with identification and counseling of overweight patients.

Design

Randomized controlled trial.

Participants

Physicians at an academic general internal medicine clinic were randomized to activation of the EHR tools (n = 15) or to usual care (n = 15). Patients of these physicians were included in analyses if they had a body mass index (BMI) between 27 and 29.9 kg/m².

Intervention

The EHR tool set included: a physician point-of-care alert for overweight (BMI 27–29. 9 kg/m²); a counseling template to help physicians counsel patients on action plans; and an order set to facilitate entry of overweight as a diagnosis and to order relevant patient handouts.

Main Measures

Physician documentation of overweight as a problem; documentation of weight-specific counseling; physician perceptions of the EHR tools; patient self-reported progress toward their goals and perspectives about counseling received.

Key Results

Patients of physicians receiving the intervention were more likely than those of usual care physicians to receive a diagnosis of overweight (22% vs. 7%; p = 0.02) and weight-specific counseling (27% vs. 15%; p = 0.02). Most patients receiving counseling in the intervention group reported increased motivation to lose weight (90%) and taking steps toward their goal (93%). Most intervention physicians agreed that the tool alerted them to patients they did not realize were overweight (91%) and improved the effectiveness of their counseling (82%); more than half (55%) reported counseling overweight patients more frequently (55%). However, most physicians used the tool infrequently because of time barriers.

Conclusions

EHR-based alerts and management tools increased documentation of overweight and counseling frequency; the majority of patients for whom the tools were used reported short-term behavior change.KEY WORDS: overweight, counseling, electronic health record     

Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin: Subanalysis of GetGoal‐S

Aims/Introduction

This was a subanalysis of Japanese patients included in the glucagon-like peptide-1 receptor agonist AVE0010 in patients with type 2 diabetes mellitus for glycemic control and safety evaluation (GetGoal-S) study – a 24-week, randomized, placebo-controlled study of lixisenatide in patients with type 2 diabetes mellitus inadequately controlled by sulfonylurea with or without metformin.

Materials and Methods

In GetGoal-S, 127 Japanese patients received the once-daily prandial glucagon-like peptide-1 receptor agonist lixisenatide 20 μg/day or a matching placebo. The primary outcome was change in glycated hemoglobin.

Results

At week 24, lixisenatide significantly reduced mean glycated hemoglobin (least squares mean difference vs the placebo −1.1% [12 mmol/mol, P < 0.0001]), and significantly more lixisenatide patients reached glycated hemoglobin targets of <7% (53 mmol/mol) and ≤6.5% (48 mmol/mol) vs the placebo. Lixisenatide produced statistically significant reductions in 2-h postprandial plasma glucose (least squares mean difference vs the placebo −8.51 mmol/L, P < 0.0001) and glucose excursion vs the placebo, and significantly reduced fasting plasma glucose (least squares mean difference vs the placebo −0.65 mmol/L, P = 0.0454). Bodyweight decreased with both lixisenatide and the placebo (least squares mean change −1.12 kg for lixisenatide, −1.02 kg for placebo). The overall incidence of adverse events was similar for lixisenatide and the placebo (84.2 and 82.4%, respectively), the most frequent being gastrointestinal disorders (52.6% for lixisenatide vs 29.4% for placebo). The incidence of symptomatic hypoglycemia was higher with lixisenatide vs the placebo (17.1 and 9.8%, respectively), with no cases of severe symptomatic hypoglycemia in either group.

Conclusions

In the Japanese subpopulation of the GetGoal-S study, lixisenatide produced a significant and clinically relevant improvement in glycated hemoglobin, with a pronounced improvement in postprandial plasma glucose, and a good safety and tolerability profile.     

Racial and Ethnic Differences in Cardio-Metabolic Risk in Individuals with Undiagnosed Diabetes: National Health and Nutrition Examination Survey 1999–2008

Background

Although early recognition and treatment of diabetes may be essential to prevent complications, roughly one-fifth of diabetes remains undiagnosed.

Objective

Examine cardio-metabolic risk factors and their control in non-Hispanic white (NHW), non-Hispanic black (NHB) and Mexican American (MA) individuals with undiagnosed diabetes.

Design

Nationally representative cross-sectional study of participants in the National Health and Nutrition Examination Survey (NHANES) continuous cycles conducted 1999 through 2008.

Participants

Of 22,621 non-pregnant individuals aged ≥20 years, 2521 had diagnosed diabetes. Of the remaining 20,100 individuals, 17,963 had HbA1c measured, 551 of whom were classified as having undiagnosed diabetes and comprise the study population.

Main Measures

Undiagnosed diabetes was defined as HbA1c ≥ 6.5% without a self-report of physician diagnosed diabetes. Cardio-metabolic risk factor control was examined using regression methods for complex survey data.

Key Results

Among individuals with undiagnosed diabetes, mean HbA1c level was 7.7% (95% CI: 7.5, 7.9), 19.3% (95% CI: 14.2, 24.3) smoked, 59.7% (95% CI: 54.5, 64.8%) had hypertension and 96.5% (95% CI: 94.6, 98.4%) had dyslipidemia. Lipid profiles were remarkably different across racial-ethnic groups: NHB had the highest LDL- and HDL-cholesterol, but the lowest triglycerides, while MA had the highest triglycerides and the lowest LDL-cholesterol. After adjusting for age, sex, NHANES examination cycle and use of either blood pressure or lipid medication, the odds of having blood pressure ≥130/80 mmHg was higher in NHB [1.92 (95% CI: 1.09, 3.55)] than NHW, while the odds of having LDL-cholesterol >100 mg/dl was higher in NHW[2.93 (95% CI: 1.37, 6.24)] and NHB[3.34 (95% CI: 1.08, 10.3)] than MA.

Conclusions

In a nationally representative sample of individuals with undiagnosed diabetes, cardio-metabolic risk factor levels were high across all racial/ethnic groups, but NHB and MA had poorer control compared to NHW. Interventions that target identification of diabetes and treatment of cardio-metabolic risk factors are needed.KEY WORDS: undiagnosed diabetes, disparities, cardio-metabolic risk, HbA1c     

Associations of Pretransplant Weight and Muscle Mass with Mortality in Renal Transplant Recipients

Summary

Background and objectives:

The association between pretransplant body composition and posttransplant outcomes in renal transplant recipients is unclear. It was hypothesized that in hemodialysis patients higher muscle mass (represented by higher pretransplant serum creatinine level) and larger body size (represented by higher pretransplant body mass index [BMI]) are associated with better posttransplant outcomes.

Design, setting, participants, & measurements:

Linking 5-year patient data of a large dialysis organization (DaVita) to the Scientific Registry of Transplant Recipients, 10,090 hemodialysis patients were identified who underwent kidney transplantation from July 2001 to June 2007. Cox regression hazard ratios and 95% confidence intervals of death and/or graft failure were estimated.

Results:

Patients were 49 ± 13 years old and included 49% women, 45% diabetics, and 27% African Americans. In Cox models adjusted for case-mix, nutrition-inflammation complex, and transplant-related covariates, the 3-month-averaged postdialysis weight-based pretransplant BMI of 20 to <22 and < 20 kg/m², compared with 22 to <25 kg/m², showed a nonsignificant trend toward higher combined posttransplant mortality or graft failure, and even weaker associations existed for BMI ≥ 25 kg/m². Compared with pretransplant 3-month- averaged serum creatinine of 8 to <10 mg/dl, there was 2.2-fold higher risk of combined death or graft failure with serum creatinine <4 mg/dl, whereas creatinine ≥14 mg/dl exhibited 22% better graft and patient survival.

Conclusions:

Pretransplant obesity does not appear to be associated with poor posttransplant outcomes. Larger pretransplant muscle mass, reflected by higher pretransplant serum creatinine level, is associated with greater posttransplant graft and patient survival.     

Association of variants in CDKN2A/2B and CDKAL1 genes with gestational insulin sensitivity and disposition in pregnant Han Chinese women

Aims/Introduction

Variants in cell cycle regulation genes, CDKAL1 and CDKN2A/2B, have been suggested to be associated with type 2 diabetes, and also play a role in insulin procession in non-diabetic European individuals. Rs7754580 in CDKAL1 and rs7020996 in CDKN2A/2B were found to be associated with gestational diabetes in Chinese individuals. In order to understand the metabolism mechanism of greatly upregulated maternal insulin signaling during pregnancy and the pathogenesis of gestational diabetes, we investigated the impact of rs7754580 and rs7020996 on gestational insulin regulation and procession.

Materials and Methods

We recruited 1,146 unrelated, non-diabetic, pregnant Han Chinese women (age 28.5 ± 4.1 years, body mass index 21.4 ± 2.6 kg/m²), and gave them oral glucose tolerance tests. The indices of insulin sensitivity, insulin disposition, insulin release and proinsulin to insulin conversion were calculated. Rs7754580 in the CDKAL1 gene and rs7020996 in the CDKN2A/2B gene were genotyped. Under an additive model, we analyzed the associations between the variants and gestational insulin indices using logistic regression.

Results

By adjusting for maternal age, body mass index and the related interactions, CDKAL1 rs7754580 risk allele C was detected to be associated with increased insulin sensitivity (P = 0.011), decreased insulin disposition (P = 0.0002) and 2-h proinsulin conversion (P = 0.017). CDKN2A/2B rs7020996 risk allele T was found to be related to decreased insulin sensitivity (P = 0.002) and increased insulin disposition (P = 0.0001).

Conclusions

The study showed that cell cycle regulating genes might have a distinctive effect on gestational insulin sensitivity, β-cell function and proinsulin conversion in pregnant Han Chinese women.     

Observational study to evaluate the safety and efficacy of saroglitazar in Indian diabetic dyslipidemia patients

Saroglitazar is a dual PPAR α/γ agonist approved in India for the management of diabetic dyslipidemia.

Aims

The objective of this study was to evaluate the safety and efficacy of saroglitazar 4 mg once daily in clinical practice.

Methods

This was an observational, multicenter, single-arm study. Patients with type 2 diabetes (with on-going antidiabetic medication), age above 18 years, and triglycerides ≥200 mg/dL were included.

Results

A total 2804 patients with a mean duration of diabetes 6.29 yrs were included in this analysis. The baseline demographic profile was: mean age of 53 yrs, mean body weight 72.3 kg and mean BMI of 27 kg/m². 62.5% patients were male and 57.8% were reported to be on statin therapy at baseline. All 2804 patients were on antidiabetic medications with 15.4% patients on monotherapy and rest were on two or more than two antidiabetic medications at baseline. The baseline triglycerides and HbA1C values were 312.3 mg/dL and 8.3% respectively. At 3 months follow-up, use of saroglitazar 4 mg led to significant reduction in TG (35.8%), LDL-C (16.4%), total cholesterol (19%) and non-HDL-C (23.4%). Addition of saroglitazar to baseline antidiabetic medications showed a significant 0.9% absolute reduction in HbA1c with significant improvement in fasting and post prandial plasma glucose. No serious adverse events, alteration in liver or renal enzymes and edema or weight gain were reported.

Conclusion

Saroglitazar is a potential therapeutic option in type 2 diabetic patients with high TG levels, not controlled by statins, for comprehensive control of lipid and glycemic parameters with acceptable safety profile.     

Strength training and risk of type 2 diabetes in a Japanese working population: A cohort study

Aims/Introduction

Muscle strength training has been suggested to improve glucose metabolism; however, epidemiological evidence regarding strength training''s effects on diabetes risk is scarce. We prospectively examined the association between strength training and the risk of type 2 diabetes in Japanese men and women.

Materials and Methods

The sample included health checkups on 26,630 Japanese male and female workers aged 30–64 years without diabetes at baseline. Weekly time spent on strength training was elicited using a self-reported questionnaire. Type 2 diabetes was diagnosed based on hemoglobin A1c, fasting glucose, random plasma glucose and self-report in an annual health checkup. Hazard ratio (HR) and its 95% confidence interval (CI) for incident diabetes was estimated using a Cox proportional hazards model.

Results

During a mean follow up of 5.2 years with 139,748 person-years, 1,770 individuals developed diabetes. Age- and sex-adjusted HR for diabetes was 0.58 (95% CI 0.42–0.79) in those who engaged in strength training compared with those who engaged in no strength training. After further adjusting for potential confounders, the corresponding HR was 0.66 (95% CI 0.48–0.90). Additional adjustment for body mass index did not materially change the result; the HR was 0.70 (95% CI 0.51–0.96). The association was more pronounced in individuals aged 50 years or older than those aged <50 years, although the difference in the association by age was not significant.

Conclusions

These results suggest that engagement in strength training could help to reduce the risk of type 2 diabetes in a Japanese working population.