Role of bile acids in glucose lowering by metformi

Phase 1

Completed

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

• Registration Number: ACTRN12619000299101
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Study Completion: 2020-03-11
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

*Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet only
*Body mass index (BMI) from 25 to 35 kg/m2
*Males and females, aged from 18 to 75 years
*Glycated haemoglobin (HbA1c) equal to 8.5%
*Haemoglobin above the lower limit of the normal range (ie. greater than 135g/L for men and 115g/L for women), and ferritin above the lower limit of normal (ie. greater than 30ng/mL for men and greater than 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 < 90 mL/min or abnormal liver function tests (> 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