Effects of intraduodenal administration of quinine on appetite, energy intake and gut hormone release, in response to a standardized buffet-style meal, in humans with type 2 diabetes.

Not Applicable

Completed

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

• Registration Number: ACTRN12621000218897
• Lead Sponsor: Professor Christine Feinle-Bisset

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-03
• Study Completion: 2023-12-13
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

Male participants with type 2 diabetes mellitus (T2DM), (aged 18-70 years BMI, 28-37 kg/m2, waist circumference: <102 cm), will be included in the study. T2DM diagnosis will be based on WHO criteria. HbA1c will be >=6.5 - <=7.9% at screening. Blood glucose medications will be required to be withheld for 48 hours prior to each study day. All participants will be required to be weight-stable (ie <5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 4 weeks.

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;
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;
HbA1c <6.5% or >7.9%;
Any patient whose medication cannot be withheld for 48 hours for medical reasons;
Estimated glomerular filtration rate <45 ml/min.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy intake at the buffet meal measured using the computer software program FoodWorks.[ A buffet meal will be presented during each study visit (t = 0-30 min), The subject will be allowed to freely consume food until comfortably full for 30 min. At 30 minutes after consumption of the meal commences, the energy intake at the buffet meal will be measured. ]