More or less? Bile acids and glycaemic control in type 2 diabetes

Phase 1

Recruiting

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

• Registration Number: ACTRN12621000877886
• Lead Sponsor: The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-07
• Last Update Posted: 15 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Type 2 diabetes (World Health Organisation (WHO) criteria) treated by metformin only (on a stable dose over the last 3 months)
• Body mass index (BMI) from 25 to 35 kg/m2
• Males and females, aged from 40 to 79 years
• Glycated haemoglobin (HbA1c) less than 7.9%
• Haemoglobin above the lower limit of the normal range (ie. above 135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. above 30ng/mL for men and above 20mg/mL for women)

Exclusion Criteria

•Use of any medication that may influence gastrointestinal motor function, body weight or appetite (opiates, anticholinergics, levodopa, clonidine, nitrates, tricyclic antidepressants, selective serotonin re-uptake inhibitors, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, prucalopride, or erythromycin)
•Evidence of drug abuse, consumption of more than 20 g alcohol or 10 cigarettes on a daily basis
•History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendicectomy or cholecystectomy)
•Other significant illness, including epilepsy, cardiovascular or respiratory disease
•Impaired renal or liver function (as assessed by calculated creatinine clearance less than 90 mL/min or abnormal liver function tests (more than 2 times upper limit of normal range))
•Donation of blood within the previous 3 months
•Participation in any other research studies within the previous 3 months
•Inability to give informed consent
•Female participants who are pregnant or planning for pregnancy, or are lactating
•Vegetarians

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference in the iAUC0-180min for plasma total GLP-1 between colesevelam and placebo treatments. [t = 0, 30, 60, 90, 120, 150 and 180 min on day 0 and 15 of each treatment period.]