Effects of L-leucine (alone or in combination with L-tryptophan or lauric acid) on gut functions, gastric emptying, gut hormone release and blood glucose control in healthy, and obese humans with type 2 diabetes

Not Applicable

Recruiting

• Conditions: Healthy Human Gastrointestinal Physiology; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Metabolic and Endocrine - Diabetes; Type 2 diabetes; Diet and Nutrition - Obesity; Obesity

• Registration Number: ACTRN12613000899741
• Lead Sponsor: Christine Feinle-Bisset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

A total of 16 healthy, lean (BMI 19-25 kg/m2) and 16 obese T2DM (BMI 30-35 kg/m2) male and female Caucasian subjects, aged between 18 - 55 years, will be included in each Study A-I. T2DM diagnosis will be based on WHO criteria. HbA1c will be >=6.5 - <=7.9% at screening. Patients will be diet-controlled, with or without metformin (<2 g/d). 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

Exclusion Criteria

Healthy Subjects: 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; individuals with low ferritin levels (females less than 15 ng/mL, males 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; in female subjects, pregnancy or lactation; restrained eaters (score >12 on the three factor eating questionnaire); fasting glucose >6.9 mmol/l or HbA1c >=6.5%.

Obese T2DM subjects: As for healthy subjects, except, HbA1c <6.5% - >7.9%; metformin medication >2g/d; estimated glomerular filtration rate <45ml/min. The degree of eating restraint will be assessed, but not used as an exclusion criteria, as obese often have some degree of eating restraint.

Study & Design

• Study Type: Interventional
• Study Design: Not specified