Clinical Trial: Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect

Brief Summary: The purpose of this study is to examine whether there is a causal relationship between insulin resistance and/or glucose intolerance in the development of a defect incretin effect.

Detailed Summary:

In this study we are going to examine the incretin effect before and after the development of insulin resistance and/or glucose intolerance. The incretin effect is the increased insulin response seen after an oral as apposed to an intravenous glucose challenge with identical plasma glucose profiles. This insulin enhancing effect is 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 incretin effect 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.

The incretin effect in this study will be examined by 3 investigations prior to the treatment and 3 days following the treatment.

Day 1: Oral glucose challenge with 75 g of glucose.

The subject is asked to drink 75g of glucose suspended in 300mL of water. During the 4 hours of the test, we draw blood at various times during the study to determine the concentration of: Glucose, GLP-1, GIP, Glucagon, Insulin and c-peptide.

Day 2: Intravenous glucose

We duplicate the glucose curve obtained from day 1. We also draw blood during this test to the same end as in day 1.

Day 3: Mixed meal.

The subjects are served a mixed meal. During this 4 hour test, we draw blood to examine the response to a standardized meal. The test involves sampling blood as described for the other days.

Sponsor: University Hospital, Gentofte, Copenhagen

Current Primary Outcome: Incremental GLP-1 response during the mixed meal test. Assessed as AUC during the 4 hour test. [ Time Frame: 4 hours (during the mixed meal test) ]

Original Primary Outcome: Incremental GLP-1 response during the mixed meal test. Assessed as AUC during the 4 hour test. [ Time Frame: In the mixed meal test ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital, Gentofte, Copenhagen

Dates:
Date Received: November 3, 2008
Date Started: November 2008
Date Completion:
Last Updated: May 19, 2014
Last Verified: May 2014