Insulinotropic Effect of GLP-1 and GIP After Dexamethasone

September 7, 2014 updated by: Carsten Dirksen, Hvidovre University Hospital

Loss of Insulinotropic Properties of Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) After Glucocorticoid Induced Insulin Resistance

In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study we are going to examine the insulinotropic properties of GLP-1 and GIP before and after the development of insulin resistance and/or glucose intolerance.The insulinotropic properties of GLP-1 and GIP are greatly reduced in type 2 diabetes.

Since the development of type 2 diabetes is preceded by insulin resistance and glucose intolerance we wanted to examine the insulinotropic properties of GLP-1 and GIP in the early stages of type 2 diabetes.

To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved by 5 days of treatment with dexamethasone.

Subjects are studied on 4 different days in randomized order, with an oral glucose tolerance test (OGTT) and glucose clamps + infusions of GLP-1, GIP and NaCl before and immediately after 5 days treatment with dexamethasone, 2mg bid. On day 1, 2 and 3 after the 5 days of dexamethasone, 2mg dexamethasone was given in the afternoon after the tests to ensure unchanged insulin resistance

Study Type

Interventional

Enrollment (Actual)

19

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
      • Copenhagen NV, Denmark, 2400
        • Bispebjerg University 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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Caucasians above 20 and below 45 years of age
  • Normal glucose tolerance as assessed by the WHO criteria
  • First degree relative and at least 1 second degree relative with type 2 diabetes
  • Normal haemoglobin
  • Informed consent

Exclusion Criteria:

  • Liver disease (ALAT/ASAT > 2 times normal value)
  • Kidney disease (S-creatinin > 130uM and/or albuminuria)
  • Heart disease (NYHA II, III or IV)
  • Treatment with medicine that cannot be paused
  • Pregnancy of breast feeding

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone
This is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days.
Drug: Dexamethasone
Dexamethasone are given dexamethasone tablets of 2mg twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l
Time Frame: 1-3 days after dexamethasone treatment
After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.
1-3 days after dexamethasone treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
First phase insulin response to GLP-1 infusion at 7mmol/l
Time Frame: 1-3 days after dexamethasone
1-3 days after dexamethasone
First phase insulin response to GIP infusion at 7mmol/l
Time Frame: 1-3 days after dexamethasone
1-3 days after dexamethasone
Second phase insulin response to GIP infusion at 7mmol/l
Time Frame: 1-3 days after dexamethasone treatment
1-3 days after dexamethasone treatment

Other Outcome Measures

Outcome Measure
Time Frame
Total insulin response to arginine infusion
Time Frame: 1-3 days after dexamethasone
1-3 days after dexamethasone

Collaborators and Investigators

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

Sponsor

Hvidovre University Hospital

Investigators

  • Study Director: Thure Krarup, dr. med., Bispebjerg Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 7, 2014

First Submitted That Met QC Criteria

September 7, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 10, 2014

Last Update Submitted That Met QC Criteria

September 7, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-D-2009-070

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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