Effect of GIP After a Meal in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.

Official Title
-----------------
Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Other: GIP(3-30)NH2
* Other: Peripheral venous cannulation
* Other: GLP-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes HbA1c < 75 mmol/mol BMI > 27 kg/m2 Stable weight (+/- 5%) during the last 3 months Exclusion Criteria: Treatment with medicine or dietary supplements that cannot the paused for 12 hours More than 14 units of alcohol weekly or abuse of drugs Liver disease, estimated at plasma ALAT levels > 3 x normal value or INR outside normal range Reduced kidney function (estimated at eGFR < 60 ml/min/1,73 m2) Severe arteriosclerotic heart disease or heart failure (NYHA III or IV) Low red blood cell count (hemoglobin < 8.3 mmol/l Special diet or planned weight change during the trial period Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GIP(3-30)NH2<br>GIP receptor antagonist | Other: GIP(3-30)NH2<br>* Peptide derived from the naturally occuring gut hormone GIP<br>Other: Peripheral venous cannulation<br>* Intravenous access for infusions<br>|
| Placebo Comparator: Placebo<br>Placebo (saline infusions) | Other: Peripheral venous cannulation<br>* Intravenous access for infusions<br>|
| Active Comparator: GLP-1<br> | Other: Peripheral venous cannulation<br>* Intravenous access for infusions<br>Other: GLP-1<br>* Peptide infusion<br>|
| Experimental: GLP-1 + GIP(3-30)NH2<br> | Other: GIP(3-30)NH2<br>* Peptide derived from the naturally occuring gut hormone GIP<br>Other: Peripheral venous cannulation<br>* Intravenous access for infusions<br>Other: GLP-1<br>* Peptide infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucagon | Plasma levels of glucagon after a meal in patients with type 2-diabetes | 8 weeks - 6 months |