Diabetes mellitus and its impact on mortality rate and outcome in pulmonary embolism

Aims/IntroductionIn patients with pulmonary embolism (PE), the impact of diabetes mellitus on patient profile and outcome is not well investigated.Material and MethodsThe German nationwide inpatient sample of the years 2005–2018 was analyzed. Hospitalized PE patients were stratified for diabetes, and the impact of diabetes on in‐hospital events was investigated.ResultsOverall, 1,174,196 PE patients (53.8% aged ≥70 years, 53.5% women) and, among these, 219,550 (18.7%) diabetes patients were included. In‐hospital mortality rate amounted to 15.8%, and was higher in diabetes patients than in non‐diabetes patients (19.8% vs 14.8%, P < 0.001). PE patients with diabetes had a higher prevalence of cardiovascular risk factors, comorbidities, right ventricular dysfunction (31.8% vs 27.7%, P < 0.001), prolonged in‐hospital stay (11.0 vs 9.0 days, P < 0.001) and higher rates of adverse in‐hospital events. Remarkably, diabetes was independently associated with increased in‐hospital mortality (odds ratio [OR] 1.21, 95% confidence interval [CI] 1.20–1.23, P < 0.001) when adjusted for age, sex and comorbidities. Within the observation period of 2005–2018, a relevant decrease of in‐hospital mortality in PE patients with diabetes was observed (25.5% to 16.8%). Systemic thrombolysis was more often administered to diabetes patients (OR 1.18, 95% CI 1.01–3.49, P < 0.001), and diabetes was associated with intracerebral (OR 1.19, 95% CI 1.12–1.26, P < 0.001), as well as gastrointestinal bleeding (OR 1.11, 95% CI 1.07–1.15, P < 0.001). Type 1 diabetes mellitus was shown to be a strong risk factor in PE patients for shock, right ventricular dysfunction, cardiopulmonary resuscitation and in‐hospital death (OR 1.75, 95% CI 1.61–1.90, P < 0.001).ConclusionsDespite the progress in diabetes treatments, diabetes is still associated with an unfavorable clinical patient profile and higher risk for adverse events, including substantially increased in‐hospital mortality in acute PE.     

Impact of the first announced state of emergency owing to coronavirus disease 2019 on stress and blood pressure levels among patients with type 2 diabetes mellitus in Japan

Aims/IntroductionAfter the first coronavirus disease 2019 state of emergency announcement, there was an increase in stress that might have affected the self‐management of patients with type 2 diabetes mellitus. This study identified the changes in clinical findings and stress among patients with type 2 diabetes mellitus, and investigated the characteristics of patients who experienced an increase in blood pressure (BP) after the announcement.Materials and MethodsRetrospectively, we scrutinized 310 patients with type 2 diabetes mellitus who were treated by the Sagamihara Physicians Association. After the announcement, 164 and 146 patients showed an increase (ΔBP >0 group) and decrease in BP (ΔBP ≤0 group), respectively. The propensity score matching method was used to compare the differences in clinical findings and stress‐related questionnaire responses between the two groups.ResultsAfter the announcement, 47% of patients experienced an increase in daily stress. Furthermore, 17% and 36% reported worsening dietary intake and a decrease in exercise, respectively. More patients reported that their dietary and salt intake had worsened in the ΔBP >0 group than in the ΔBP ≤0 group (9% vs 20%, P = 0.02, and 3% vs 10%, P = 0.04, respectively). Additionally, both systolic and diastolic BP measured in the office were significantly increased (P = 0.02 and P = 0.03, respectively); however, systolic BP measured at home significantly decreased (P = 0.01). The total stress scores were higher in the ΔBP >0 group than in the ΔBP ≤0 group (0.05 ± 2.61 and 0.93 ± 2.70, respectively, P = 0.03).ConclusionsAn increase in stress and, particularly, worsening dietary and salt intake were noted among patients with type 2 diabetes mellitus who experienced an increase in BP after the state of emergency announcement.     

Clinical characteristics of non‐small cell lung cancer patients with EGFR mutations and ALK&ROS1 fusions

ObjectiveTo study the relationship between clinical characteristics and anaplastic lymphoma kinase (ALK) fusions, c‐ros oncogene 1, receptor tyrosine kinase (ROS1) gene fusions, and epidermic growth factor receptor (EGFR) mutations in non‐small cell lung cancer (NSCLC) patients to distinguish these different types.MethodsBoth ALK, ROS1 gene rearrangements and EGFR mutations testing were performed. The clinical characteristics and associated pulmonary abnormalities were investigated.ResultsFour hundred fifty‐three NSCLC patients were included for analysis. One hundred seventy (37.5%), 32 (7.1%), and 9 cases (2.0%) with EGFR mutations, ALK gene fusions, and ROS1 gene fusions were identified, respectively. The EGFR‐positive and ALK&ROS1‐positive were more common in female (χ ² = 61.934, P < 0.001 and χ ² = 28.152, P < 0.001), non‐smoking (χ ² = 59.315, P < 0.001 and χ ² = 11.080, P = 0.001), and adenocarcinoma (χ ² = 44.864, P < 0.001 and χ ² = 12.318, P = 0.002) patients; proportion of patients with emphysema was lower (χ ² = 35.494, P < 0.001 and χ ² = 15.770, P < 0.001) than the wild‐type patients. The results of logistic regression analysis indicated that female (adjusted odds ratio [OR] 1.834, 95% confidence interval [CI] 1.069–3.144, P = 0.028), non‐smoking (adjusted OR 2.504, 95% CI 1.456–4.306, P = 0.001), lung adenocarcinoma (adjusted OR 4.512, 95% CI 2.465–8.260, P < 0.001), stage III–IV (adjusted OR 2.232, 95% CI 1.066–4.676, P = 0.033), and no symptoms of emphysema (adjusted OR 2.139, 95% CI 1.221–3.747, P = 0.008) were independent variables associated with EGFR mutations. Young (adjusted OR 3.947, 95% CI 1.873–8.314, P < 0.001) and lung adenocarcinoma (adjusted OR 2.950, 95% CI 0.998–8.719, P = 0.050) were associated with ALK/ROS1 fusions.Conclusions EGFR mutations were more likely to occur in non‐smoking, stage III–IV, and female patients with lung adenocarcinoma, whereas ALK&ROS1 gene fusions were more likely to occur in young patients with lung adenocarcinoma. Emphysema was less common in patients with EGFR mutations.     

Effectiveness and Acceptability of a Mobile Phone Text Messaging Intervention to Improve Blood Pressure Control (TEXT4BP) among Patients with Hypertension in Nepal: A Feasibility Randomised Controlled Trial

Background:Uncontrolled blood pressure (BP) is the leading cause of preventable deaths in low- and middle-income countries. mHealth interventions, such as mobile phone text messaging, are a promising tool to improve BP control, but research on feasibility and effectiveness in resource-limited settings remains limited.Objective:This feasibility study assessed the effectiveness and acceptability of a mobile phone text messaging intervention (TEXT4BP) to improve BP control and treatment adherence among patients with hypertension in Nepal.Methods:The TEXT4BP study was a two-arm, parallel-group, unblinded, randomised controlled pilot trial that included 200 participants (1:1) (mean age: 50.5 years, 44.5% women) with hypertension at a tertiary referral hospital in Kathmandu, Nepal. Patients in the intervention arm (n = 100) received text messages three times per week for three months. The control arm (n = 100) received standard care. The COM-B model informed contextual co-designed text messages. Primary outcomes were change in BP and medication adherence at three months. Secondary outcomes included BP control, medication adherence self-efficacy and knowledge of hypertension. A nested qualitative study assessed the acceptability of the intervention.Results:At three months, the intervention group had greater reductions in systolic and diastolic BP vs usual care [–7.09/–5.86 (p ≤ 0.003) vs –0.77/–1.35 (p ≥ 0.28) mmHg] [adjusted difference: systolic β = –6.50 (95% CI, –12.6; –0.33) and diastolic BP β = –4.60 (95% CI, –8.16; –1.04)], coupled with a greater proportion achieving target BP (70% vs 48%, p = 0.006). The intervention arm showed an improvement in compliance to antihypertensive therapy (p < 0.001), medication adherence (p < 0.001), medication adherence self-efficacy (p = 0.023) and knowledge on hypertension and its treatment (p = 0.013). Participants expressed a high rate of acceptability and desire to continue the TEXT4BP intervention.Conclusion:The TEXT4BP study provides promising evidence that text messaging intervention is feasible, acceptable, and effective to improve BP control in low-resource settings.Trial registration:anzctr.org.au Identifier ACTRN12619001213134.     

Frequent scanning using flash glucose monitoring contributes to better glycemic control in children and adolescents with type 1 diabetes

Aims/IntroductionWe examined the impact of scanning frequency with flash glucose monitoring on glycemic control in children and adolescents with type 1 diabetes.Materials and MethodsThe study included 85 patients, aged 14.0 ± 0.5 years, with type 1 diabetes. The median time in the target glucose range (TIR) and glycosylated hemoglobin (HbA1c) values were 50.0 ± 1.4% and 7.5 ± 0.1%, respectively.ResultsThe median scanning frequency using flash glucose monitoring was 12.0 ± 0.4 times/day. Scanning frequency showed a significant positive correlation with TIR and an inverse correlation with HbA1c. Scanning frequency was identified to be the determinant of TIR and HbA1c by using multivariate analysis. The participants whose scanning frequency was <12 times/day were categorized as the low‐frequency group (n = 40), and those who carried out the scanning >12 times/day were categorized as the high‐frequency group (n = 45). Patients in the high‐frequency group were more likely to be treated with insulin pumps compared with those in the low‐frequency group; however, this difference was not significant (21.3 vs 5.3%, P = 0.073). The high‐frequency group showed significantly greater TIR than the low‐frequency group (57 ± 1.6 vs 42 ± 1.7%, P = 0.002). Furthermore, the high‐frequency group showed significantly lower HbA1c levels than the low‐frequency group (6.8 ± 0.1 vs 8.0 ± 0.1%, P < 0.001).ConclusionsThese findings showed that patients with a higher scanning frequency had better glycemic control, with greater TIRs and lower HbA1c levels, compared with those with a lower scanning frequency. Scanning frequency of >12 times/day might contribute to better glycemic outcomes in real‐world practice in children with type 1 diabetes.     

Global prevalence of prediabetes in children and adolescents: A systematic review and meta‐analysis

BackgroundPrediabetes is a pivotal risk factor for developing diabetes. This meta‐analysis was performed to assess the global prevalence of childhood prediabetes.MethodsA systematic search was conducted for studies of prediabetes prevalence in the general pediatric population from inception until December 2021. Random‐effects meta‐analysis was used to combine the data. Variations in the prevalence estimates in different subgroups (age group, sex, setting, investigation period, body mass index [BMI] group, family history of diabetes, diagnosis criteria, World Health Organization [WHO] and World Bank [WB] regions) were examined by subgroup meta‐analysis.ResultsA total of 48 studies were included in the meta‐analysis. The pooled prevalence was 8.84% (95% CI, 6.74%‐10.95%) for prediabetes in childhood. Subgroup meta‐analyses showed that the prevalence was higher in males than females (8.98% vs 8.74%, P < .01), in older compared to younger children (7.56% vs. 2.51%, p < 0.01), in urban compared to rural areas (6.78% vs. 2.47, p < 0.01), and higher in children with a family history of diabetes than in those without such a history (7.59% vs. 6.80%, p < 0.01). We observed an upward trend in prediabetes prevalence from 0.93% to 10.66% over past decades (p < 0.01). The pooled prevalence increased from 7.64% to 14.27% with increased BMI (p < 0.01). Pooled prevalence was the lowest for criterion A among different diagnosis criteria (p < 0.01). For WHO and WB regions, the European Region and high‐income countries yielded the lowest pooled prevalence (p < 0.01).ConclusionsElevated prediabetes prevalence in childhood reaches an alarming level. Intensive lifestyle modification is needed to improve the prediabetes epidemic.     

Ratio of hepatic arterial flow to recipient body weight predicts biliary complications after deceased donor liver transplantation

ObjectivesAdequate hepatic arterial (HA) flow to the bile duct is essential in liver transplantation. This study was conducted to determine if the ratio of directly measured HA flow to weight is related to the occurrence of biliary complications after deceased donor liver transplantation.MethodsA retrospective review of 2684 liver transplants carried out over a 25-year period was performed using data sourced from a prospectively maintained database. Rates of biliary complications (biliary leaks, anastomotic and non-anastomotic strictures) were compared between two groups of patients with HA flow by body weight of, respectively, <5 ml/min/kg (n = 884) and ≥5 ml/min/kg (n = 1800).ResultsPatients with a lower ratio of HA flow to weight had higher body weight (92 kg versus 76 kg; P < 0.001) and lower HA flow (350 ml/min versus 550 ml/min; P < 0.001). A lower ratio of HA flow to weight was associated with higher rates of biliary complications at 2 months, 6 months and 12 months (19.8%, 28.2% and 31.9% versus 14.8%, 22.4% and 25.8%, respectively; P < 0.001).ConclusionsA ratio of HA flow to weight of < 5 ml/min/kg is associated with higher rates of biliary complications. This ratio may be a useful parameter for application in the prevention and early detection of biliary complications.     

Lifestyle changes and their impact on glycemic control and weight control in patients with diabetes during the coronavirus disease 2019 pandemic in Japan

Aims/IntroductionThis study aimed to reveal lifestyle changes and their impact on glycemic control and weight control in patients with diabetes during the coronavirus disease 2019 (COVID‐19) pandemic in Japan.Materials and MethodsWe retrospectively analyzed 1,402 outpatients with diabetes at a clinic in Osaka, Japan, who responded to an interview sheet regarding lifestyle changes during the COVID‐19 pandemic between 28 March and 30 May 2020. The association of lifestyle changes with hemoglobin A1c (HbA1c) and weight changes from February to May 2020 was investigated using the linear regression model. We also investigated the association with clinically important change of HbA1c (by ≥0.3%) and bodyweight (by ≥3%), using the cumulative link model.ResultsLeisure time and other outside physical activities were decreased in one‐quarter of patients during the COVID‐19 pandemic, whereas the amount of meals and snacks was decreased and increased in approximately 10%, respectively. The change in leisure time physical activities was inversely associated with HbA1c and weight changes, whereas the quantitative change of meals with the decline in eating out and that of snacks were positively associated with HbA1c and weight changes (all P < 0.05). The quantitative change of meals without the decline in eating out was also positively associated with weight change (P = 0.012). The cumulative link model for clinically important HbA1c and weight change showed broadly similar associations, except for that between snacks and bodyweight (P = 0.15).ConclusionsA considerable number of outpatients with diabetes experienced lifestyle changes during the COVID‐19 pandemic. The lifestyle changes were associated with HbA1c and weight changes.     

Heart rate‐corrected QT interval: A novel diagnostic biomarker for diabetic peripheral neuropathy

Aims/IntroductionTo explore the relationship between heart rate‐corrected QT (QTc) interval and diabetic peripheral neuropathy (DPN), and whether QTc interval has diagnostic utility for DPN beyond nerve conduction velocity.Materials and MethodsA total of 965 patients with diabetes, including 473 patients with DPN and 492 patients without DPN, underwent standard 12‐lead electrocardiography and detailed assessments of peripheral neuropathy.ResultsPatients with DPN had longer QTc intervals than those without. Among participants, from the first to fourth quartile of QTc interval, the proportion of patients with DPN appreciably increased and the nerve conduction velocity obviously decreased (P for trend <0.001). The univariate and multivariate analyses showed that prolonged QTc interval was closely associated with increased risk of DPN (univariable odds ratio 1.112, 95% confidence interval 1.097–1.127, P < 0.001; multivariable odds ratio 1.118, 95% confidence interval 1.099–1.137, P < 0.001). Receiver operating characteristic analysis for the diagnosis of DPN showed a greater area under the curve for QTc interval of 0.894 than the median nerve motor conduction velocity of 0.691, median nerve sensory conduction velocity of 0.664 and peroneal nerve motor conduction velocity of 0.692. The optimal cut‐off point of QTc interval for DPN was 428.5 ms with sensitivity of 0.715 and specificity of 0.920 (P < 0.001). The combination of QTc interval and nerve conduction testing increased the area under the curve for the diagnosis of DPN (from 0.736 to 0.916; P < 0.001).ConclusionsQTc interval with 428.5 ms has more reliable diagnostic utility for DPN than nerve conduction velocity, and prolonged QTc interval is closely associated with an increased risk of DPN.     

Bariatric surgery versus medical treatment in mildly obese patients with type 2 diabetes mellitus in Japan: Propensity score‐matched analysis on real‐world data

Aims/IntroductionTo compare glycemic control 1 year after treatment in patients with mildly obese (body mass index 27.5–34.9 kg/m²) type 2 diabetes mellitus who underwent bariatric surgery (BS) to those who received medical treatment (MT) in Japan.Materials and MethodsA retrospective study using real‐world data was carried out in electronic medical records from a tertiary care hospital and in the Japanese Medical Data Center Inc. claim database from 2008 to 2019. Each patient was propensity score‐matched between the BS and the MT group by age, sex, body mass index, glycated hemoglobin and type 2 diabetes mellitus duration, and compared from the index date to the 1 year post‐index.ResultsThe study included 78 patients in the BS group and 238 patients in the MT group. The mean body mass index in the BS and the MT group was 32.1 and 32.0 kg/m², respectively. In the BS group, the patients underwent either laparoscopic sleeve gastrectomy with or without duodenojejunal bypass. The diabetes remission rate (glycated hemoglobin <6.5% without diabetes medication) at 1 year was 59.0% in the BS group and 0.4% in the MT group (P < 0.0001). Optimal glycemic control of glycated hemoglobin <7.0% was achieved in 75.6% in the BS group and in 29.0% in the MT group (P < 0.0001). The median monthly drug costs for metabolic syndrome decreased from $US126.5 (at baseline) to $US0.0 (at 1 year) in the BS group, whereas it increased from $US52.4 to $US58.3 in the MT group.ConclusionsBS for mildly obese patients with type 2 diabetes mellitus is more clinically‐ and cost‐effective than MT in Japan.     

Insulin resistance limits corneal nerve regeneration in patients with type 2 diabetes undergoing intensive glycemic control

Aims/IntroductionThis study aimed to investigate whether insulin resistance (IR) in individuals with type 2 diabetes undergoing intensive glycemic control determines the extent of improvement in neuropathy.Materials and MethodsThis was an exploratory substudy of an open‐label, randomized controlled trial of individuals with poorly controlled type 2 diabetes treated with exenatide and pioglitazone or insulin to achieve a glycated hemoglobin <7.0% (<53 mmol/mol). Baseline IR was defined using homeostasis model assessment of IR, and change in neuropathy was assessed using corneal confocal microscopy.ResultsA total of 38 individuals with type 2 diabetes aged 50.2 ± 8.5 years with (n = 25, 66%) and without (n = 13, 34%) IR were studied. There was a significant decrease in glycated hemoglobin (P < 0.0001), diastolic blood pressure (P < 0.0001), total cholesterol (P < 0.01) and low‐density lipoprotein (P = 0.05), and an increase in bodyweight (P < 0.0001) with treatment. Individuals with homeostasis model assessment of IR <1.9 showed a significant increase in corneal nerve fiber density (P ≤ 0.01), length (P ≤ 0.01) and branch density (P ≤ 0.01), whereas individuals with homeostasis model assessment of IR ≥1.9 showed no change. IR was negatively associated with change in corneal nerve fiber density after adjusting for change in bodyweight (P < 0.05).ConclusionsNerve regeneration might be limited in individuals with type 2 diabetes and IR undergoing treatment with pioglitazone plus exenatide or insulin to improve glycemic control.     

A Text Messaging Intervention With Financial Incentive for Adolescents With Type 1 Diabetes

Background:Adolescents with type 1 diabetes (T1D) have higher hemoglobin A1C (HbA1c) levels than others. In general, adolescents engage with text messaging (TM) and financial incentives, both associated with improved diabetes outcomes. This study aimed to assess the impact of a TM intervention with financial incentives on self-care behaviors and HbA1c.Methods:A six-month randomized controlled trial compared MyDiaText™, a TM education and support application, with standard care. The sample included 166 teens with T1D, 12-18 years old, attending a diabetes clinic. The intervention group received one daily TM and were instructed to respond. Participants who responded to TMs for the most consecutive days were eligible for a financial reward biweekly via lottery. All participants received prompts to complete the self-care inventory (SCI) at baseline, 90, and 180 days. HbA1c was collected at clinic visits. Changes in SCI and HbA1c were analyzed using a multilevel mixed-effects linear regression model. Intention-to-treat and per-protocol analyses were performed.Results:The median TM response rate was 59% (interquartile range 40.1%-85.2%) and decreased over time. After adjustment for baseline characteristics, in per-protocol analysis, there was a statistically significant difference in SCI score increase in those receiving one TM per day vs control (P = .035). HbA1c decreased overall, without significant difference between groups (P = .786).Conclusions:A TM intervention with financial incentives for adolescents with T1D in suboptimal control was associated with increasing self-care report; however, glycemic control did not differ from controls. Further research is needed to develop digital health interventions that will impact glycemic control.     

Dissociation Between Long-term Weight Loss Intervention and Blood Pressure: an 18-month Randomized Controlled Trial

BackgroundObesity is associated with elevated blood pressure (BP). In patients with obesity and hypertension, weight loss lowers BP, but the long-term effect of weight loss on BP is less clear.ObjectiveWe aimed to assess the effect of long-term weight loss intervention on BP in normotensive and hypertensive subjects.DesignRandomized controlled trial.ParticipantsTwo hundred seventy-eight subjects (mean age 47.9 ± 9.3 years, 89% male, 56% hypertensive) with abdominal obesity or elevated serum triglycerides and low high-density lipoprotein cholesterol were recruited.InterventionEighteen-month weight loss intervention.Main MeasuresBody weight and BP were measured at baseline, after 6 and 18 months.ResultsAfter 6 months of intervention, in the weight loss phase, body mass index (BMI) decreased by an average of −2.2±1.5 kg/m² (p<0.001) and both diastolic BP (DBP) and systolic BP (SBP) decreased by −2.1±8.8 mmHg and −2.3±12.9 mmHg, respectively (p<0.01 for both). The change in BMI was similar in normotensive and hypertensive subjects (−2.0±1.6 and −2.3±1.5, p = 0.246). However, DBP and SBP decreased significantly (−5.2±7.1 mmHg and −6.2±12.5 mmHg, respectively, p<0.001 for both) in hypertensive subjects, and increased in normotensive subjects (1.8±9.3 mmHg, p = 0.041 and 2.7±11.7 mmHg, p = 0.017, respectively). After 18 months, in the weight maintenance phase, BMI slightly increased (0.9±1.3 kg/m², p<0.001) but remained significantly lower than at baseline (p<0.0001). Unlike BMI, DBP and SBP increased significantly in hypertensive subjects (p<0.001) and returned almost to baseline levels.ConclusionWeight-loss intervention reduced BP in hypertensive patients, but this was not maintained in the long run.Clinical Trial RegistrationClinicalTrials.gov Identifier: {"type":"clinical-trial","attrs":{"text":"NCT01530724","term_id":"NCT01530724"}}NCT01530724KEY WORDS: blood pressure, weight loss, body mass index, hypertension, randomized controlled trial     

Digital therapeutics for essential hypertension using a smartphone application: A randomized,open‐label,multicenter pilot study

Hypertension is the most considerable but treatable risk factor for cardiovascular disease. Although physicians prescribe multiple antihypertensive drugs and promote lifestyle modifications, the real‐world blood pressure (BP) control rate remains poor. To improve BP target achievement, we developed a novel digital therapeutic—the HERB software system —to manage hypertension. Here, we performed a randomized pilot study to assess the safety and efficacy of the HERB system for hypertension. We recruited 146 patients with essential hypertension from March 2018 to March 2019. We allocated eligible patients to the intervention group (HERB system + standard lifestyle modification) or control group (standard lifestyle modification alone). The primary outcome was the mean change from baseline to 24 weeks in 24‐hour systolic BP (SBP) measured by ambulatory blood pressure monitoring (ABPM). The baseline characteristics in each group were well balanced; the mean age was approx. 57 years, and 67% were male. In the primary end point at 24 weeks, HERB intervention did not lower the mean change of 24‐hour SBP by ABPM compared with the controls (adjusted difference: −0.66 mmHg; p = .78). In an exploratory analysis focusing on antihypertensive drug‐naïve patients aged <65, the effects of the HERB intervention were significantly greater than the control for reducing 24‐hour SBP by ABPM at 16 weeks (adjusted difference: −7.6 mmHg; p = .013; and morning home SBP at 24 weeks (adjusted difference − 6.0 mmHg; p = .012). Thus, the HERB intervention did not achieve a primary efficacy end point. However, we observed that antihypertensive drug‐naïve adult hypertensive patients aged <65 years could be a potential HERB system‐effective target for further investigations of the efficacy of the system.     

Insulin–glucagon‐like peptide‐1 receptor agonist relay and glucagon‐like peptide‐1 receptor agonist first regimens in individuals with type 2 diabetes: A randomized,open‐label trial study

Aims/IntroductionGlucagon‐like peptide‐1 receptor agonists (GLP‐1 RA) might be less effective in patients with severe hyperglycemia, because hyperglycemia downregulated the GLP‐1 receptor in an animal study. To examine this hypothesis clinically, we compared the glucose‐lowering effects of GLP‐1 receptor agonist liraglutide with and without prior glycemic control.Materials and MethodsIn an open‐label, parallel trial, participants with poorly controlled type 2 diabetes were recruited and randomized to receive once‐daily insulin therapy, degludec (Insulin–GLP‐1 RA relay group, mean 16.8 ± 11.4 IU/day), for 12 weeks and then liraglutide for 12 weeks or subcutaneous injections of GLP‐1 RA, liraglutide (GLP‐1 RA first group, 0.9 mg), for 24 weeks. The primary efficacy end‐points consisted of changes in the levels of fasting plasma glucose and glycated hemoglobin (HbA1c).ResultsThe median fasting plasma glucose and HbA1c before the study were 210.0 mg/dL and 9.8%, respectively. The levels of fasting plasma glucose and HbA1c significantly decreased in the Insulin–GLP‐1 RA relay group (P < 0.001) and GLP‐1 RA first group (P < 0.001) by week 24, although no intergroup differences were observed. The reduction of HbA1c in the Insulin–GLP‐1 RA relay group tended to be larger than that in the GLP‐1 RA first group in the lowest CPR (C‐peptide immunoreactivity) quartile (P = 0.072). The adverse events consisted of gastrointestinal problems, followed by hypoglycemia.ConclusionsThe GLP‐1 receptor agonist is overall effective without prior glycemic control with insulin in participants with poorly controlled type 2 diabetes. However, in participants with insulinopenic type 2 diabetes, prior glycemic control with insulin might overcome glucose toxicity‐induced GLP‐1 resistance.     

Effects of individualized administration of folic acid on prothrombotic state and vascular endothelial function with H-type hypertension: A double-blinded,randomized clinical cohort study

Background:Hypertension and hyperhomocysteinemia (HHcy) have long been associated with adverse cardiovascular and cerebrovascular health outcomes. This study evaluated the effect of individualized administration of folic acid (FA) on homocysteine (Hcy) levels, prothrombotic state, and blood pressure (BP) in patients with H-type hypertension (combination of HHcy and hypertension).Methods:In this double-blinded, randomized clinical cohort study, 126 patients with H-type hypertension who were treated at our hospital were randomly divided into treatment and control groups (n = 55 each). The control group was treated with oral levamlodipine besylate tablets 2.5 mg and placebo, once a day (in the morning). The treatment group was first treated with oral levamlodipine besylate 2.5 mg and FA tablets 0.8 mg, once a day (in the morning), for 12 weeks. Then, in a second 12-week phase, the FA dose was adjusted using the methylene tetrahydrofolate reductase C677 polymorphism genotype. The levels of Hcy and coagulation factors, prothrombotic state parameters, BP, and adverse drug reactions were compared between the 2 groups.Results:Pretreatment general patient characteristics, including Hcy levels, were similar between the 2 groups (P > .05). BP and prothrombotic status did not differ before and after the first phase of treatment (P > .05). However, Hcy and endothelin-1 (ET-1) levels decreased, while nitric oxide levels increased significantly in the intervention group (P < .05). In the second phase, after 3 months’ treatment with an FA dose adjusted according to methylene tetrahydrofolate reductase C677T genotype, the Hcy and ET-1/NO levels were significantly decreased in the intervention group and were lower than those after the first treatment phase and lower than in the control group (P < .01). BP, D-dimer levels, and fibrinogen scores were significantly lower after the second treatment phase (P < .01). There was no significant difference in the incidence of adverse drug reactions between the 2 groups (P > .05).Conclusions:Individualized administration of FA tablets can effectively reduce BP, and Hcy and coagulation factor levels, and significantly improve prothrombotic status in patients with H-type hypertension.     

Abdominal volume index trajectories and risk of diabetes mellitus: Results from the China Health and Nutrition Survey

Aims/IntroductionAbdominal obesity is a risk factor for developing diabetes mellitus, but trajectories of abdominal obesity over time and incident diabetes mellitus have not been considered. We derived trajectories of abdominal volume index (AVI) over 16 years of follow up, and examined the associations between AVI trajectories and risk of diabetes mellitus.Materials and MethodsData were used from the China Health and Nutrition Survey, and 5,267 participants were enrolled to fit the trajectory of AVI by using latent class growth models. Multivariate logistic regression models explored the relationship between different AVI trajectories and risk of diabetes mellitus. In addition, we examined the slope of the AVI trajectories in relation to age to identify appropriate life course intervention opportunities for the prevention of diabetes mellitus.ResultsThree trajectories were derived reflecting graded categories in the speed and slope of increase in AVI over time: slow, intermediate and fast increase group, respectively. After multivariate adjustment, the odds ratios for diabetes mellitus among those in the intermediate and fast increase groups were 1.81 (95% confidence interval 1.37–2.38, P < 0.001) and 2.80 (95% confidence interval 1.85–4.24, P < 0.001) respectively, relative to the slow increase group. The distribution of AVI slope in the slow increase group showed an inverted "U" shape, whereas the fast increase group presented a "U" shape.ConclusionsAVI trajectory is associated with an increased risk of diabetes mellitus. These results provide new insights on the relationship between abdominal adiposity and diabetes mellitus, which in turn can help improve clinical and public health intervention for diabetes mellitus prevention.     

Genetic susceptibility,family history of diabetes and healthy lifestyle factors in relation to diabetes: A gene–environment interaction analysis in Chinese adults

Aims/IntroductionTo analyze the associations and interactions of the genetic susceptibility and family history of diabetes with lifestyle factors in relation to diabetes among Chinese adults.Materials and MethodsWe constructed a genetic risk score of 34 single‐nucleotide polymorphisms in 11,596 participants from Songnan and Youyi communities, Baoshan District, Shanghai, China. We determined a healthy lifestyle by a normal body mass index (<24 kg/m²), adequate fruit and vegetable intake (≥4.5 cups/day), never smoked or quit smoking >1 year prior, sufficient physical activity (≥600 metabolic equivalent minutes per week), and a sleep duration of ≥6 to ≤8 h/day. Logistic regression models were used to examine the associations and interactions between heritability and lifestyle on diabetes.ResultsA healthier lifestyle was associated with a lower prevalence of diabetes within any heritable risk groups categorized by the genetic risk score and family history of diabetes. In the combined communities, the odds ratio (95% confidence interval) for diabetes associated with each additional healthy lifestyle factor was 0.83 (0.77–0.89) among participants with a low genetic risk score and 0.86 (0.81–0.91) among participants with a high genetic risk score (P _interaction = 0.66). Similar interaction patterns of family history (P _interaction = 0.15) and the combination of family history and the genetic risk score with healthy lifestyle (P _interaction = 0.55) on diabetes were observed.ConclusionsA healthier lifestyle was associated with a significantly lower prevalence of diabetes regardless of heritable risk groups, highlighting the importance of adhering to a healthy lifestyle for diabetes prevention among the entire population.     

Relationships between fasting glucose levels,lifestyle factors,and metabolic parameters in Korean adults without diagnosis of diabetes mellitus

BackgroundWe investigated the associations between fasting glucose level ranges with lifestyle factors and metabolic profiles among adults without previous diagnosis of diabetes.MethodsWe analyzed 13 625 adults without previous diagnosis of diabetes from the Korea National Health and Nutrition Examination Survey during 2016 to 2018. We categorized fasting glucose levels (mg/dl) as follows: <90, 90 to 99, 100 to 109, 110 to 124, and ≥125. We evaluated trends in the proportions of individuals with obesity, abdominal, obesity, current smoking, heavy drinking, and low physical activity according to these categories, and the odds for uncontrolled blood pressure (BP), low‐density lipoprotein cholesterol (LDL‐C), triglycerides (TG), and high‐density lipoprotein cholesterol (HDL‐C) for each fasting glucose level compared to a fasting glucose level of <90 mg/dl.ResultsThe proportions of individuals with obesity, abdominal obesity, and heavy drinking increased according to fasting glucose level (P for trend <.05). The odds for BP ≥140/90 mm Hg, TG ≥150 mg/dl, HDL‐C < 40 mg/dl in men, and HDL‐C < 50 mg/dl in women increased with increasing fasting glucose levels; however, the odds for LDL‐C ≥ 130 mg/dl increased with increasing fasting glucose levels only in women. The increases in odds for uncontrolled BP and lipid profiles were mostly observed for fasting glucose levels ≥90 mg/dl.ConclusionsEfforts are needed to prevent increased fasting glucose levels, as higher levels, even within normal range, were associated with poor metabolic profiles.