Can loss of response to the gut hormone, glucose-dependent insulinotropic polypeptide (GIP), be reversed in type 2 diabetes?

Phase 1

Recruiting

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

• Registration Number: ACTRN12619000305123
• Lead Sponsor: niversity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-27
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

•Type 2 diabetes (World Health Organisation (WHO) criteria), managed by diet and/or metformin (stable dose for equal to 3 months) only
•Body mass index (BMI) from 20 to 35 kg/m2
•Males and females, aged from 40 to 79 years
•Glycated haemoglobin (HbA1c) from 7.1 to 8.0%
•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