Effect of GIP After a Meal in Patients With Type 2 Diabetes (GA-7)

April 23, 2021 updated by: Signe Stensen, University Hospital, Gentofte, Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Center for Diabetes Research, Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Signe Stensen, MD, Center for diabetes research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

January 23, 2018

Study Completion (Actual)

January 23, 2018

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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