- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00784745
Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Copenhagen, Denmark, 2300
- Bispebjerg Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dexamethasone
|
2mg morning and night for 5 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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)
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4 hours (during the mixed meal test)
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Collaborators and Investigators
Investigators
- Principal Investigator: Thure Krarup, dr. med., Bispebjerg Hospital
Publications and helpful links
General Publications
- Henriksen JE, Alford F, Ward GM, Beck-Nielsen H. Risk and mechanism of dexamethasone-induced deterioration of glucose tolerance in non-diabetic first-degree relatives of NIDDM patients. Diabetologia. 1997 Dec;40(12):1439-48. doi: 10.1007/s001250050847.
- Jensen DH, Aaboe K, Henriksen JE, Volund A, Holst JJ, Madsbad S, Krarup T. Steroid-induced insulin resistance and impaired glucose tolerance are both associated with a progressive decline of incretin effect in first-degree relatives of patients with type 2 diabetes. Diabetologia. 2012 May;55(5):1406-16. doi: 10.1007/s00125-012-2459-7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Hyperinsulinism
- Hyperglycemia
- Glucose Intolerance
- Insulin Resistance
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
Other Study ID Numbers
- H-D-2008-087
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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