Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Tolerance

June 20, 2011 updated by: Glostrup University Hospital, Copenhagen

Insulinotropic Effect of GIP and GLP-1 Before and After Reduced Glucose Induced by Steroid Treatment, Relative Physical Inactivity and High Calorie Diet

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The incretin effect in patients with type two diabetes is reduced. The investigators have previously shown that it is possible to induce a defect in the incretin effect in healthy individuals. The purpose of this study is to evaluate the insulinotropic affect of the incretin hormones in healthy individuals before and after a deterioration of the glucose homeostasis. The evaluation is done by infusing GIP, GLP-1 or saline during hyperglycemic clamps.

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
      • Glostrup, Denmark, DK-2600
        • Department of Clinical Physiology

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Caucasians without type 2 diabetes mellitus
  • Normal OGTT (75 g of glucose) according to WHO's criteria
  • BMI 20-30
  • Hemoglobin > 8.0 mmol/l
  • Informed consent

Exclusion Criteria:

  • Liver disease (ALAT > 2 x normal level)
  • Nephropathy (s-creatinin > 130 µM or albuminuria)
  • Relatives (parents/siblings) with T2DM
  • Medical treatment witch cannot be stopped for 12 hours

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No intervention
Each participant is examined during a normal, active lifestyle, without any intervention: The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl
Other: No intervention
Experimental: Intervention
Each participant is examined during a 12 days intervention.The examinations include an OGTT, a glucagon test, three hyperglycemic clamps with infusion of a)GLP-1; b)GIP; c)Nacl
Behavioral: Steroid hormone
Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day
Other Names:
  • Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulinotropic effect of incretin hormones
Time Frame: 12 days
Measurements of the insulinotropic effect of incretin hormones before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity
12 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma concentration of glucagon
Time Frame: 12 days
Measurements of plasma concentration of glucagon before and after 12 days intervention with steroid treatment, high calorie diet and relative physical inactivity
12 days

Collaborators and Investigators

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

Sponsor

Glostrup University Hospital, Copenhagen

Collaborators

University of Copenhagen
European Foundation for the Study of Diabetes

Investigators

  • Principal Investigator: Katrine B Hansen, MD, Glostrup University Hospital
  • Study Chair: Filip K Knop, MD,PhD, Gentofte University Hospital
  • Study Chair: Tina Vilsbøll, MD,DmSc, Gentofte University Hospital
  • Study Chair: Jens J Holst, MD, DmSc, University of Copenhagen

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

April 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

June 7, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

June 21, 2011

Last Update Submitted That Met QC Criteria

June 20, 2011

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYS-CLAMP

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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