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

This study has been completed.
Information provided by (Responsible Party):
Kasper Aaboe, University Hospital, Gentofte, Copenhagen Identifier:
First received: November 3, 2008
Last updated: May 19, 2014
Last verified: May 2014
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.

Condition Intervention
Insulin Resistance
Glucose Intolerance
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect

Resource links provided by NLM:

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • 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) ]

Enrollment: 21
Study Start Date: November 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dexamethasone Drug: Dexamethasone
2mg morning and night for 5 days.

Detailed Description:

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.


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Caucasians >20 years
  • 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
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Please refer to this study by its identifier: NCT00784745

Bispebjerg Hospital
Copenhagen, Denmark, 2300
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Principal Investigator: Thure Krarup, dr. med. Bispebjerg Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kasper Aaboe, Doctor, University Hospital, Gentofte, Copenhagen Identifier: NCT00784745     History of Changes
Other Study ID Numbers: H-D-2008-087
Study First Received: November 3, 2008
Last Updated: May 19, 2014

Keywords provided by University Hospital, Gentofte, Copenhagen:
incretin effect
type 2 diabetes

Additional relevant MeSH terms:
Insulin Resistance
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017