Gastrointestinal mechanisms underlying glucose lowering by metformin in type 2 diabetes

Phase 2

Completed

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

• Registration Number: ACTRN12617000243314
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-17
• Study Completion: 2018-10-10
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet only
Body mass index (BMI) 20 - 40 kg/m2
Males and post-menopausal females
Glycated haemoglobin (HbA1c) less than 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 within 48 hours or 5 half-lives of the study, specifically: opiates, anticholinergics, levodopa, clonidine, nitrates, phosphodiesterase type 5 inhibitors, sumatriptan, metoclopramide, domperidone, cisapride, tegaserod, or erythromycin
Evidence of drug abuse, or 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 (greater 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
Females who are pre-menopausal
Inability to give informed consent
Participants who do not eat beef
Vegetarian diet

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
differences in the incremental area under the curve (iAUC) for plasma glucose between the 3 treatments. [at t = -60, -45, -30, -15, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min where t = -60 is when the intraluminal catheter is correctly positioned and t = 0 is when oral glucose given.];differences in the incremental area under the curve (iAUC) for plasma GLP-1 between the 3 treatments. [at t = -60, -30, 0, 15, 30, 45, 60, 90, 120, 150 and 180 min where t = -60 is when the intraluminal catheter is correctly positioned and t = 0 is when oral glucose given.];differences in the gastric half-emptying time (T50) derived from 13CO2 concentrations in the breath samples between the 3 treatments. [breath samples collected immediately before (t=0) and every 5 min after oral glucose in the first hour and every 15 min for a further 2 hours. t = 0 is when oral glucose is given.]