Effects of intragastric administration of L-leucine and L-isoleucine on gastric emptying, gut hormone release and blood glucose in normal weight, overweight or obese type 2 diabetic patients.

Not Applicable

Completed

• Conditions: Type 2 diabetes; Obesity; Diet and Nutrition - Obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619000413123
• Lead Sponsor: Christine Feinle-Bisset

Brief Summary

Our investigation showed that in individuals with T2D, while both leucine and isoleucine stimulated insulin, in contrast to health, only isoleucine significantly stimulated glucagon, and neither amino acid slowed gastric emptying or diminished the glycaemic response to a carbohydrate-containing drink, underlining the critical role of gastric emptying in the regulation of postprandial blood glucose control.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-13
• Study Completion: 2019-09-19
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

A total of 14 lean, overweight or obese T2DM (BMI 19-37 kg/m2) male and female subjects, aged between 18 - 70 years, will be included in the study. T2DM diagnosis will be based on WHO criteria (i.e. HbA1c will be >=6.5 - <=7.9%). Patients will be diet-controlled or required to cease oral blood glucose lowering medication 48 hours before participatiing in the study. All subjects will be required to be weight stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceeding 4 weeks. Subjects will be required to maintain their normal physical activity over the course of the study, which will be assessed using diaries. Females will be required to be postmenopausal.

Exclusion Criteria

Significant gastrointestinal symptoms, disease or surgery;
Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, gastrointestinal function, body weight or appetite (eg domperidone and cisapride, anticholinergic drugs (eg atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)
Lactose intolerance/other food allergy(ies)
Current gallbladder or pancreatic disease
Cardiovascular or respiratory diseases
Those with low ferritin levels (less than 30 ng/mL), or who have donated blood in the 12 weeks prior to taking part in the study
Any other illnesses as assessed by the investigator (including chronic illnesses not explicitly listed above)
High performance athletes
Current intake of greater than 2 standard drinks on greater than 5 days per week
Current smokers of cigarettes/cigars/marijuana
Current intake of any illicit substance
Vegetarians
Inability to comprehend study protocol
Restrained eaters (score >12 on the three factor eating questionnaire). The degree of eating restraint will be assessed for all, but not used as an exclusion criteria for overweight or obese subjects, as overweight and obese often have some degree of eating restraint
HbA1c <6.5% - >7.9%; metformin medication >2g/d
Estimated glomerular filtration rate <45ml/min

Study & Design

• Study Type: Interventional
• Study Design: Not specified