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

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ClinicalTrials.gov Identifier: NCT00784745
Recruitment Status : Completed
First Posted : November 4, 2008
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Insulin Resistance Glucose Intolerance Drug: Dexamethasone

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect
Study Start Date : November 2008
Primary Completion Date : August 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dexamethasone Drug: Dexamethasone
2mg morning and night for 5 days.


Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00784745


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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kasper Aaboe, Doctor, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00784745     History of Changes
Other Study ID Numbers: H-D-2008-087
First Posted: November 4, 2008    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by Kasper Aaboe, University Hospital, Gentofte, Copenhagen:
incretin effect
type 2 diabetes
GLP-1
GIP
dexamethasone

Additional relevant MeSH terms:
Insulin Resistance
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Dexamethasone acetate
Dexamethasone
BB 1101
Incretins
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action