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

Overview

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.

Full Title of Study: “Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 23, 2018

Interventions

  • Other: GIP(3-30)NH2
    • Peptide derived from the naturally occuring gut hormone GIP
  • Other: Peripheral venous cannulation
    • Intravenous access for infusions
  • Other: GLP-1
    • Peptide infusion

Arms, Groups and Cohorts

  • Experimental: GIP(3-30)NH2
    • GIP receptor antagonist
  • Placebo Comparator: Placebo
    • Placebo (saline infusions)
  • Active Comparator: GLP-1
  • Experimental: GLP-1 + GIP(3-30)NH2

Clinical Trial Outcome Measures

Primary Measures

  • Glucagon
    • Time Frame: 8 weeks – 6 months
    • Plasma levels of glucagon after a meal in patients with type 2-diabetes

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Gentofte, Copenhagen
  • Provider of Information About this Clinical Study
    • Principal Investigator: Signe Stensen, MD – University Hospital, Gentofte, Copenhagen
  • Overall Official(s)
    • Signe Stensen, MD, Principal Investigator, Center for Diabetes Research

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