Overview

The Insulin Response to the Gut Hormone GIP After Near-normalisation of Plasma Glucose in Patients With Type 2 Diabetes

Status:
Recruiting
Trial end date:
2020-09-01
Target enrollment:
Participant gender:
Summary
The investigators hypothesise that the insulinotropic effect of endogenous GIP is improvable in patients with type 2 diabetes after three weeks of near-normalisation of plasma glucose. To test this hypothesis, a randomised, placebo-controlled, double-blinded, crossover study employing a GIP receptor antagonist, will be carried out. Fifteen overweight (body mass index (BMI) > 25 kg/m2) dysregulated (HbA1c > 59 mmol/mol) patients with type 2 diabetes will attend two experimental days followed by a three-week period of plasma glucose near-normalisation (achieved by standard treatment of type 2-diabetes), followed by another two experimental days. On experimental days, patients will receive an infusion of GIP receptor antagonist or placebo during a 75 g oral glucose tolerance test. The primary endpoint is changes in levels of C-peptide divided by changes in levels of plasma glucose and secondary endpoints include changes in circulating levels of C-peptide, insulin, glucose, GIP, glucagon-like peptide 1 (GLP-1), glucagon and markers of bone turnover as well as indices of beta cell function. Furthermore, gastric emptying rate will be assessed.
Phase:
N/A
Details
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Treatments:
Empagliflozin
Gastric Inhibitory Polypeptide
Insulin
Insulin, Globin Zinc
Metformin