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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by University Hospital, Gentofte, Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00784745
First received: November 3, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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: In the mixed meal test ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: September 2009
Estimated 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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784745

Contacts
Contact: David H. Jensen, stud. med. +45 35 31 50 84 DJEN0051@regionh.bbh.dk
Contact: Thure Krarup, dr. med +45 35 31 27 24 TKRA0008@regionh.bbh.dk

Locations
Denmark
Bispebjerg Hospital Recruiting
Copenhagen, Denmark, 2300
Sub-Investigator: David H. Jensen, stud. med         
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Thure Krarup, dr. med. Bispebjerg Hospital
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thure Krarup, dr. med., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT00784745     History of Changes
Other Study ID Numbers: H-D-2008-087
Study First Received: November 3, 2008
Last Updated: November 3, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by 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
Dexamethasone 21-phosphate
BB 1101
Incretins
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014