New therapeutic approaches to diabetic gastroparesis.]

CASE HISTORY AND PHYSICAL EXAMINATION: A 24-year-old man with type 1 diabetes, nonresponding to standard treatment for severe gastroparesis, was admitted to hospital due to persisting nausea and vomiting. Further known complications included diabetic retinopathy, diabetic nephropathy with mild renal impairment, diabetic peripheral and cardiac autonomic neuropathy, and arterial hypertension. EXAMINATIONS: Gastric motility parameters were evaluated by functional scintigraphy. Gastric emptying was severely delayed showing first appearance of food in duodenum after 25 min. After 60 min, technetium activity in the stomach was still detected in considerable amounts. The 50% emptying time was 58 min (normal time 10-20 min). A detailed symptom score for gastroparesis, prospectively investigated by a standardized patient diary, showed a severe and complex clinical disturbance: the frequency of daily attacks of impulsive vomiting ranged from 2 to 21 and the mean daily duration of nausea was 7.5 h. A value of 3.4 on the scale for a premature feeling of satiety (range 0-4, normal = 0) was determined, as well as scores of 2.5 for symptoms of abdominal bloating (range 0-3, normal = 0) and 3.7 for general well-being (range 0-4, normal = 0). COURSE OF DISEASE AND TREATMENT: Pharmacological interventions with antibiotics, prokinetics, antiemetics and, as a second step, percutaneous gastrostomy (first invervention) and jejunostomy (second intervention) were not long-term effective in reducing the clinical symptoms described above. Therefore, a single intrapyloric injection with 100 U of botulinum toxin was performed leading to a prompt and significant improvement of symptoms and an adequate oral nutrient intake the day after the procedure. Determined by gastric scintigraphy 1 week later, this led to a significant reduction of the 50% emptying time (36 min) and to an improvement of the symptom score for gastroparesis as determined 4 weeks later: frequency of daily attacks of impulsive vomiting ranged from 0 to 1, mean daily duration of nausea was 1 h, premature feeling of satiety (score 1.9), symptoms of abdominal bloating (1.1), and general well-being (2.1). The beneficial effect of the botulinum toxin injection was unchanged over 3 months, slightly diminishing by 4.5 months. After a second round of botulinum toxin injection, again, prompt relief of most of the symptoms was achieved. Percutaneous jejunostomy was then revised. CONCLUSION: Intrapyloric injection of botulinum toxin is effective in improving the complex symptoms and clinical syndrome associated with diabetic gastroparesis resistant to conventional treatment. Upon waning of the therapeutic effect over time, the procedure can be repeated with success.     

Update on gastroparesis.

Gastroparesis is a manifestation of diabetic autonomic neuropathy. Gastrointestinal autonomic neuropathy contributes to morbidity, mortality, reduced quality of life, and increased healthcare costs of a patient with diabetes mellitus. Complications from gastroparesis include ketoacidosis, infection, and bezoar formation. The gold standard for the diagnosis of gastroparesis is a gastric emptying study. Other tests and procedures may also be performed to eliminate other causes of the symptoms. In general, treatment involves dietary and lifestyle adjustment as well as pharmacological interventions. Gastric electrical stimulation has recently emerged as an effective strategy in the management of these patients. Research is evolving in this area to include the use of botulinum toxin to control symptoms of gastroparesis. Patients with gastroparesis can be frustrated with the symptoms they experience, the intensive treatment regimens they must follow, as well as the medical procedures they undergo during the course of their treatment. Quality of life is an important factor to consider when caring for and supporting these patients. This article will provide an overview of gastroparesis and the latest treatments available to improve gastric motility and prevent further complications.     

Delayed gastric emptying and gastric autoimmunity in type 1 diabetes

OBJECTIVE: Delayed gastric emptying and/or gastrointestinal symptoms occur in 30-50% of diabetic patients. Known contributing factors are autonomic neuropathy and acute hyperglycemia, but the role of gastric autoimmunity has never been investigated, although 15-20% of type 1 diabetic patients exhibit parietal cell antibodies (PCAs). We studied gastric motility in diabetes in relation to PCA status, autonomic nerve function, HbA(1c), thyroid-stimulating hormone (TSH), Helicobacter pylori (HP), acid production, and gastric histology. RESEARCH DESIGN AND METHODS: Gastric emptying of solids and liquids (measured by (13)C-octanoic acid and (13)C-glycine breath tests, respectively) was tested in euglycemic conditions in 42 type 1 diabetic patients (male/female: 29/13; 15 PCA+; mean age 40 +/- 15 years; mean HbA(1c) 7.8 +/- 0.9%). Gastrointestinal symptoms, autonomic nerve function (Ewing tests), PCA status (indirect immunofluorescence), gastric histology, and acid secretion (pentagastrin) were assessed. RESULTS: Solid gastric emptying was delayed in 40% and liquid emptying in 36% of patients. Gastric motility did not correlate with symptoms. PCA status, gastric morphology, and acid secretion were similar in those with and without gastroparesis. HbA(1c) level (beta = 1.34, P = 0.011) was the only risk factor for delayed solid emptying in a logistic regression model testing HbA(1c), autonomic nerve function, PCA, HP status, age, sex, diabetes duration, and TSH. Half-emptying time for liquids correlated with TSH level (r = 0.83, P < 0.0001) and autonomic neuropathy score (r = -0.79, P = 0.001). CONCLUSIONS: We found that approximately 50% of type 1 diabetic patients studied had delayed gastric emptying that did not correlate with symptoms. Gastric autoimmunity did not contribute to diabetic gastroparesis. Metabolic control was worse in patients with delayed solid emptying.     

Effect of motilin on gastric emptying in patients with diabetic gastroparesis

OBJECTIVES: Because disturbances of gastric emptying are a serious complication in insulin-dependent diabetic subjects with regard to the maintenance of good metabolic control, we wanted to assess the effectiveness of motilin as a potential treatment for gastric emptying disturbances. RESEARCH DESIGN AND METHODS: The intestinal hormone motilin has been shown to accelerate gastric emptying in healthy subjects. Therefore, we examined the effect of intravenous motilin on gastric emptying of a 99mTc colloid-labeled semisolid test meal in 9 insulin-dependent diabetic patients with diabetic gastroparesis. All patients had a significantly delayed gastric emptying rate compared with a group of 11 healthy control subjects. RESULTS: During the infusion of motilin, gastric emptying was accelerated, and it was no longer significantly different from control values. CONCLUSIONS: These data demonstrate that motilin and related compounds such as erythromycin derivatives could be useful for the treatment of disturbed gastric emptying in diabetic subjects.     

Predictors of delayed gastric emptying in diabetes.

OBJECTIVE: To define the predictors of the rate of gastric emptying in patients with diabetes. RESEARCH DESIGN AND METHODS: A total of 101 outpatients with diabetes (79 type 1 and 22 type 2) underwent measurements of gastric emptying of a solid/liquid meal (scintigraphy), upper gastrointestinal symptoms (questionnaire), glycemic control (blood glucose concentrations during gastric emptying measurement), and autonomic nerve function (cardiovascular reflexes). RESULTS: The gastric emptying of solid and/or liquid was delayed in 66 (65%) patients. Solid (retention at 100 min 64 +/- 3.2 vs. 50.2 +/- 3.6%, P < 0.005) and liquid (retention at 100 min 22.7 +/- 1.7 vs. 16.0 +/- 1.8%, P < 0.001) gastric emptying was slower in women than in men. Of all upper gastrointestinal symptoms (including nausea and vomiting), only abdominal bloating/fullness was associated with slower gastric emptying (P < 0.005). A multiple regression analysis demonstrated that both abdominal bloating/fullness and female sex were predictors of slower gastric emptying of both solids and liquids. CONCLUSIONS: We conclude that the presence of abdominal bloating/fullness but not any other upper gastrointestinal symptom is associated with diabetic gastroparesis and that gastric emptying is slower in diabetic women than in diabetic men.     

胃镜下胃壁注射A型肉毒毒素治疗单纯性肥胖的临床研究

目的 研究胃镜下胃壁注射A型肉毒毒素(BTX-A)治疗单纯性肥胖的减重疗效和安全性.方法 19例单纯性肥胖患者随机分为试验组Ⅰ(BTX-A 200 U)和试验组Ⅱ(BTX-A 300 U),胃镜下将药物注射于胃壁肌层共20个点,治疗前和治疗后1周、4周、12周分别对进食量、体重、BMI、腰围、臀围、胃固体排空时间、胃电图等进行随访.结果 两组患者治疗后进食量较治疗前明显减少(P<0.05);体重、BMI、腰围、臀围均明显减少(P<0.05);胃固体半排空时间明显延长(P<0.05),胃延迟相时间延长,但无统计学差异;胃电图各指标治疗前后无明显变化.无明显不良反应发生.结论 胃镜下注射BTX-A能减慢胃排空、减少进食量,安全有效地减轻体重.     

Botulinum toxin type A as a migraine preventive treatment. For the BOTOX Migraine Clinical Research Group

OBJECTIVE: To assess the safety and efficacy of botulinum toxin type A (BOTOX; Allergan, Inc) in the prevention of migraine. BACKGROUND: Current migraine preventive therapies are often unsatisfactory because of their limited efficacy, adverse effects, and drug interactions. Botulinum toxin type A injections often reduce the pain associated with conditions such as cervical dystonia, achalasia, rectal fissures, and myofascial pain syndrome. An open-label, noncontrolled study of botulinum toxin type A suggested benefits for patients with migraine. DESIGN AND METHODS: This was a double-blind, vehicle-controlled study of 123 subjects with a history of two to eight moderate-to-severe migraine attacks per month, with or without aura. Participants were randomized to receive single administrations of vehicle or botulinum toxin type A, 25 U or 75 U, injected into multiple sites of pericranial muscles at the same visit. During a 1-month baseline period and for 3 months following injection, subjects kept daily diaries in which they recorded migraine frequency, migraine severity, and the occurrence of migraine-associated symptoms. RESULTS: Compared with vehicle treatment, subjects in the 25-U botulinum toxin type A treatment group showed significantly fewer migraine attacks per month, a reduced maximum severity of migraines, a reduced number of days using acute migraine medications, and reduced incidence of migraine-associated vomiting. Both the 25-U and 75-U botulinum toxin type A groups were significantly better than the vehicle group on subject global assessment. Botulinum toxin A treatment was well tolerated, with only the 75-U treatment group exhibiting a significantly higher rate of treatment-related adverse events than vehicle. CONCLUSIONS: Pericranial injection of botulinum toxin type A, 25 U, was found to be a safe treatment that significantly reduced migraine frequency, migraine severity, acute medication usage, and associated vomiting.     

Prevalence of delayed gastric emptying in diabetic patients and relationship to dyspeptic symptoms: a prospective study in unselected diabetic patients

OBJECTIVE: Data on the prevalence of abnormal gastric emptying in diabetic patients are still lacking. The relation between gastric emptying and dyspeptic symptoms assessed during gastric emptying measurement has not yet been investigated. The aim was to investigate the prevalence of delayed gastric emptying in a large cohort of unselected diabetic patients and to investigate the relation between gastric emptying and gastrointestinal sensations experienced in the 2 weeks before and during the test meal, prospectively. RESEARCH DESIGN AND METHODS: Gastric emptying was evaluated in 186 patients (106 with type 1 diabetes, mean duration of diabetes 11.6 +/- 11.3 years) using 100 mg (13)C-enriched octanoic acid added to a solid meal. RESULTS: Gastric emptying was significantly slower in the diabetic subjects than in the healthy volunteers (T(50): 99.5 +/- 35.4 vs. 76.8 +/- 21.4 min, P < 0.003; Ret(120 min): 30.6 +/- 17.2 vs. 20.4 +/- 9.7%, P < 0.006). Delayed gastric emptying was observed in 51 (28%) diabetic subjects. The sensations experienced in the 2 weeks before the test were weakly correlated with the sensation scored during the gastric emptying test. Sensations assessed during the gastric emptying test did predict gastric emptying to some extent (r = 0.46, P < 0.0001), whereas sensations experienced in the previous 2 weeks did not. CONCLUSIONS: This prospective study shows that delayed gastric emptying can be observed in 28% of unselected patients with diabetes. Upper gastrointestinal sensations scored during the gastric emptying tests do predict the rate of gastric emptying to some extent and sensation experienced during daily life does not.     

Pilot study on gastric electrical stimulation on surgery-associated gastroparesis: long-term outcome

OBJECTIVES: Patients with postgastric surgery gastroparesis are often unresponsive to conventional medical therapy. Gastric electrical stimulation (GES) with the use of high-frequency and low-energy neural stimulation is an approved technique for patients with idiopathic and diabetic gastroparesis. METHODS: We hypothesized that GES would improve symptoms, health resource utilization, and gastric emptying in six patients with postsurgical gastroparesis from a variety of surgical procedures. Patients were evaluated by means of the following criteria: symptoms, health-related quality of life, and gastric emptying tests at baseline over time. RESULTS: All patients noted improvements after device implantation for up to 46 months: the frequency score for weekly vomiting went from a baseline of 3.2 down to 0.4 immediately after treatment before settling at 1.4 by the long-term follow up. Total gastrointestinal symptom score went from 36.5 at baseline down to 12.3 before settling at 20.5 at long-term follow up. Improvements were also seen in health-related quality of life and solid and liquid gastric emptying. CONCLUSIONS: We conclude that GES is associated with clinical improvements in this group of patients with either postsurgical or surgery-associated gastroparesis. This pilot study with long-term outcomes offers evidence for a new therapy for otherwise refractory patients with gastroparesis associated with previous surgery.     

Natural history of diabetic gastroparesis

OBJECTIVE: The major aim of this study was to evaluate the prognosis of diabetic gastroparesis. RESEARCH DESIGN AND METHODS: Between 1984 and 1989, 86 outpatients with diabetes (66 type 1, 20 type 2; 40 male, 46 female) underwent assessment of solid and liquid gastric emptying and esophageal transit (by scintigraphy), gastrointestinal symptoms (by questionnaire), autonomic nerve function (by cardiovascular reflex tests), and glycemic control (by HbAlc and blood glucose concentrations during gastric emptying measurement). These patients were followed up in 1998. RESULTS: Of the 86 patients, solid gastric emptying (percentage of retention at 100 min) was delayed in 48 (56%) patients and liquid emptying (50% emptying time) was delayed in 24 (28%) patients. At follow-up in 1998, 62 patients were known to be alive, 21 had died, and 3 were lost to follow-up. In the group who had died, duration of diabetes (P = 0.048), score for autonomic neuropathy (P = 0.046), and esophageal transit (P = 0.032) were greater than in those patients who were alive, but there were no differences in gastric emptying between the two groups. Of the 83 patients who could be followed up, 32 of the 45 patients (71%) with delayed solid emptying and 18 of the 24 patients (75%) with delay in liquid emptying were alive. After adjustment for the effects of other factors that showed a relationship with the risk of dying, there was no significant relationship between either gastric emptying or esophageal transit and death. CONCLUSIONS: In this relatively large cohort of outpatients with diabetes, there was no evidence that gastroparesis was associated with a poor prognosis.     

A型肉毒杆菌毒素治疗面肌痉挛235例临床研究

目的探讨A型肉毒杆菌毒素(BTXA)治疗面肌痉挛(HFS)的疗效及副作用.方法对235例HFS病人进行面肌多点注射BTXA,对治疗前后的病情分级进行比较,并随访12～36周.结果BTXA治疗的总有效率为98.3%(231/235),无全身反应,半年复发率为60%,药效作用时间平均16周;重复注射同样有效.结论局部注射BTXA是治疗HFS的一种有效手段.     

糖尿病患者固体胃排空测定的醋氨酚试验——附46例报告

目的：了解糖尿病患者的胃排空情况。方法：应用醋氨酚试验测定了４６例糖尿病患者和１６名正常人的胃排空,以胃排空值（３小时内血清醋氨酚浓度与时间曲线下面积）和排空指数（３小时内血清醋氨酚高峰浓度所对应的时间／峰值）两个参数判断胃排空情况。结果：糖尿病组胃排空值显著下降,排空指数显著升高;与正常人比较Ｐ＜０．０５,糖尿病组胃排空延迟发生率为３０％。结论：针对糖尿病患者的诊疗特点,固体醋氨酚试验为研究糖尿病胃动力障碍的较好方法。     

Effect of intramuscular botulinum toxin injection on upper limb spasticity in stroke patients

OBJECTIVE: To evaluate the therapeutic effect of intramuscular injection of botulinum toxin on spasticity of the upper limb, with emphasis on its influence over limb function. DESIGN: An open-label, noncontrolled trial with a duration of 12 wk was designed to determine the safety and efficacy of intramuscular botulinum toxin A injection in the treatment of 16 patients with stroke with spastic hemiparesis. Electromyographically guided intramuscular botulinum toxin A injections were applied to the spastic limbs. A detailed scale system was used for the evaluation of muscle tone and functional changes induced by botulinum toxin A treatment. RESULTS: No major side effect secondary to botulinum toxin A injection was reported. Statistically significant (P < 0.05) improvements of muscle tone, joint range of motion, hand muscle strength, and muscular pain were seen after the injection. The improvements lasted up to 8-12 wk after the treatment. However, there was no significant functional improvement except in two of the patients. CONCLUSIONS: Botulinum toxin A injection may help relieve upper limb spasticity and pain in patients with stroke. Its effect on function is probably determined by case selection.     

胃轻瘫犬固体胃排空特征的超声评价

目的 探讨清醒状态下胃轻瘫比格犬的固体胃排空特征。方法 采用双侧迷走神经干切断术联合胰高血糖素复制胃轻瘫犬动物模型,运用超声成像技术评价比格犬正常和胃轻瘫状态下固体胃排空功能,并与核素SPECT闪烁成像结果进行比较。结果 比格犬的固体胃排空过程符合改良的指数模型：Y=1-(1-e-k1)β,胃轻瘫比格犬的胃半排时间较正常显著延长,差异具有统计学意义(P＜0.05)。结论 胃轻瘫比格犬的固体胃排空特征具有稳定的数学表达方式。     

Erythromycin in the Treatment of Diabetic Gastroparesis

The macrolide antibiotic erythromycin has been known to be associated with increased gastrointestinal motility since its introduction more than 35 years ago. Investigators have, thus, sought to take advantage of this side effect in patients with gastric stasis secondary to long-standing insulin-dependent diabetes mellitus (IDDM). The hormone motilin induces phase 3 contractions of the migrating motor complex (MMC) to induce peristalsis and facilitate gastric emptying in normal subjects. Patients with diabetic gastroparesis lack adequate phase 3 activity to effectively empty gastric contents. Exogenous motilin administered to animals and patients with diabetic gastroparesis has proven useful for promoting gastric emptying. However, motilin is expensive to produce and must be given intravenously. Erythromycin has been shown to induce premature phase 3 activity via stimulation of motilin receptors, so investigators evaluated its efficacy for the treatment of diabetic gastroparesis. Early studies in animals with experimental gastroparesis indicated that erythromycin may be a useful prokinetic agent. Human studies of both intravenous erythromycin and chronic oral erythromycin in patients with diabetic gastroparesis resistant to other prokinetic agents showed that gastric retention was indeed reduced and symptomatic improvement achieved. Even though erythromycin lost some of its prokinetic activity with chronic oral dosing, gastric retention was still significantly reduced compared to placebo or baseline. Although prokinetic agents like metoclopramide, domperidone and cisapride are effective for the treatment of patients with diabetic gastroparesis, tachyphylaxis and adverse effects are obstacles to their use. Erythromycin appears to be both effective and well tolerated in clinical studies. At this time it should be reserved for the treatment of patients with diabetic gastroparesis who are resistant to or intolerant of other prokinetic agents. Future research on erythromycin's long-term safety and comparative efficacy will further define its role.     

Understanding diabetic gastroparesis: a case study.

The purpose of this article is to present an overview of diabetic gastroparesis, defined as delayed gastric emptying in the absence of mechanical obstruction. Diabetic gastroparesis is a substantial and unrecognized problem. Failure to treat may result in a decreased quality of life and a potential increase for morbidity. The treatment protocol for diabetic gastroparesis combines dietary and pharmacologic measures. This article will discuss normal physiology of gastric emptying along with the pathogenesis of delayed emptying in patients with diabetes. Nursing implications for the care of the patient with diabetic gastroparesis is also presented along with commonly used pharmacologic agents.     

Botulinum toxin type B in piriformis syndrome

OBJECTIVE: To evaluate the clinical safety and efficacy of botulinum toxin type B (MYOBLOC) in reducing myofascial pain associated with piriformis syndrome. DESIGN: This was a single-center, outpatient, open-label study of patients with piriformis syndrome. Subjects were treated unilaterally or bilaterally, depending on their symptoms. Evaluations and procedures were performed by a single examiner who was not blinded, and there were no control subjects in this case series. Each piriformis muscle was infiltrated from one injection site under electromyographic guidance with 5000 units of botulinum toxin type B. RESULTS: A total of 20 patients were enrolled in this study. Significant reductions in mean visual analog scale scores for buttock and hip pain were noted at weeks 4, 12, and 16 and for low back pain at weeks 2, 12, and 16. Visual analog scale scores for general and low back pain, pain radiating into lower limbs, and tingling were significantly lower at week 2 after injection, suggesting early onset. A total of 95% of patients reported fair to excellent improvement in pain. Botulinum toxin type B was considered to have fair to excellent efficacy in 90% of patients, as evaluated by the investigator rating of overall efficacy. Botulinum toxin treatment was well tolerated. Dry mouth was the most common treatment emergent adverse event, reported in 6 of 20 patients. CONCLUSIONS: Findings suggest the possibility that botulinum toxin type B may be of potential benefit in the treatment of pain attributed to piriformis syndrome.     

三黄脂消饮对糖尿病胃轻瘫大鼠血糖和胃排空率的改变

[摘要] 目的 研究三黄脂消饮对糖尿病胃轻瘫大鼠血糖和胃排空率的改变。方法 以三黄脂消饮治疗糖尿病胃轻瘫模型大鼠，并与正常组及模型组比较。结果 中药治疗后血糖下降，胃排空率增加。 结论 三黄脂消饮不仅可以降低糖尿病血糖水平，而且增加了并发症胃轻瘫的胃排空率，明显地改善了胃排空延迟，所以三黄脂消饮是治疗糖尿病胃轻瘫的有效药物。     

糖尿病大鼠瘦素和下丘脑瘦素功能受体的表达与胃排空的关系

目的探讨糖尿病不同阶段胃排空障碍与血清瘦素及其下丘脑OB-Rb表达的关系。方法40只Wistar大鼠随机分为对照饲养1周组（NC1组；n=6）、对照饲养4周组（NC2组；n=6）、糖尿病造模1周组（DM1组；n=14）和糖尿病造模4周组（DM2组；n=14）。分别于给药后1周、4周用酚红灌胃法检测胃排空；用放射免疫法、半定量RT—PCR技术检测大鼠血清瘦素及其下丘脑OB-Rb mRNA的表达。结果注射STZ1周后，DM1组大鼠血清瘦素明显低于NC1组（P〈0．05）；下丘脑OB-Rb mRNA表达明显低于NC1组；液体胃排空是加快的（P〈0．01）。注射STZ4周后，DM2组大鼠血清瘦素和胃排空明显低于NC2组（P〈0．05；P〈0．01）；DM2组下丘脑组织OB—Rb mRNA的表达明显高于NC2组（P〈0．05）。结论Ⅰ型糖尿病早期，机体可能通过降低血清瘦素和反应性的下调下丘脑OB-Rb表达，以加快胃排空。维持能量平衡。而长期高血糖及低瘦素水平可能反馈性的引起下丘脑OB-Rb表达上调，参与胃排空延迟。     

A paracetamol‐pasta test for assessing gastric emptying in healthy and diabetic subjects

Previous studies have shown that the relationship between gastrointestinal symptoms and gastric emptying is weak. Therefore the quantitative assessment of gastric emptying with a relatively simple, non‐invasive test would be of considerable clinical value in insulin‐treated diabetic patients to identify those with disturbed gastric emptying. The aim of this investigation was to evaluate the inter‐ and intra‐subject variability of a paracetamol‐pasta test in healthy subjects and in IDDM patients. Eighteen healthy subjects (8 women) with a mean age of 37 years (range 19–68) and 19 IDDM patients (10 women) with a mean age of 48 years (range 25–62) and mean duration of diabetes of 28 years (range 6–52) were studied on two occasions with an interval of 1 to 4 weeks. After an overnight fast the subjects ingested a standardized pasta meal mixed with 2?g paracetamol in a period of 15?min. Blood samples were drawn at regular intervals after meal intake and analysed for paracetamol (P) and blood glucose. The serum levels of P were significantly lower at 15?min in diabetic patients. The intra‐subject coefficients of variation (CV%) of the areas under the serum paracetamol concentration‐time curve (AUC) were almost identical in healthy and diabetic subjects, while the intra‐subject CV of the P‐Tmax was considerably lower in diabetic patients as well as markedly lower than the corresponding inter‐subject CV. The inter‐subject CVs of all parameters calculated were generally higher in diabetic patients. This study indicates that the assessment of paracetamol absorption kinetics during a paracetamol‐pasta test is reproducible in healthy as well as in diabetic subjects. Diabetic patients with non‐optimal glucose control and without a case history indicating gastro‐duodenal motor function disturbances achieve lower serum concentration of P at 15?min and generally display a higher inter‐individual variability indicative of subclinical disturbances of gastric emptying in this group of patients.