A randomised placebo controlled crossover trial to evaluate the effects of different doses of taurocholic acid in an enema formulation on gastrointestinal hormone secretion and appetite in healthy humans for the future design of treatments for Type 2 diabetes mellitus and obesity

Phase 1

Completed

• Conditions: Designing future treatments for type 2 diabetes mellitus; Designing future treatments for obesity; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12611000071921
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

Healthy subjects; Body mass index (BMI) 19 - 30 kg/m2; Haemoglobin > 135 g/

Exclusion Criteria

Medications affecting gut function; Alcohol intake >20g daily or cigarette smoking; Significant gastrointestinal disease or surgery; Impaired liver or renal function; Blood donation within 3 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plasma concentrations of glucagon-like peptide- 1 (GLP-1), Peptide YY (PYY), and oxyntomodulin[T= -5, 10, 30, 60, 90, 120, 180 min, where the enema is administered at T=0 min]

Secondary Outcome Measures

Name	Time	Method
Appetite scores by visual analogue questionnaire[T= -5, 10, 30, 60, 90, 120, 180 min, where the enema is administered at T=0 min];Food intake from an ad libitum buffet meal[Offered over 30 minutes, from 180 - 210 min after the enema is administered]