![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
University Hospital, Gentofte, Copenhagen |
---|---|
Information provided by: | University Hospital, Gentofte, Copenhagen |
ClinicalTrials.gov Identifier: | NCT00784745 |
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: | Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect |
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 |
---|---|
Dexamethasone: Experimental |
Drug: Dexamethasone
2mg morning and night for 5 days.
|
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Denmark | |
Bispebjerg Hospital | Recruiting |
Copenhagen, Denmark, 2300 | |
Sub-Investigator: David H. Jensen, stud. med |
Principal Investigator: | Thure Krarup, dr. med. | Bispebjerg Hospital |
Responsible Party: | Bispebjerg Hospital ( Thure Krarup, dr. med. ) |
Study ID Numbers: | H-D-2008-087 |
Study First Received: | November 3, 2008 |
Last Updated: | November 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00784745 |
Health Authority: | Denmark: Ethics Committee |
incretin effect type 2 diabetes GLP-1 GIP dexamethasone |
Dexamethasone Metabolic Diseases Glucose Intolerance Diabetes Mellitus Insulin Glucagon-Like Peptide 1 Hyperinsulinism |
Hyperglycemia Diabetes Mellitus, Type 2 Insulin Resistance Glucose Metabolism Disorders Metabolic disorder Dexamethasone acetate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics |
Glucocorticoids Hormones Pharmacologic Actions Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |