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| Sponsored by: |
University Hospital, Gentofte, Copenhagen |
|---|---|
| Information provided by: | University Hospital, Gentofte, Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00803296 |
Purpose
The incretin effect is markedly reduced in patients with type 2 diabetes. Data support the notion that this deficiency is a consequence of the diabetic state. However, the impact of insulin resistance on the incretin effect in obese individuals who uphold a normal glucose tolerance (NGT) despite their insulin resistant state remains to be elucidated. The primary aim of the present study is to evaluate the separate impact of one of the cornerstones of type 2 diabetic pathophysiology, namely insulin resistance, on the incretin effect in lean and obese patients with type 2 diabetes and in two matched normal-glucose tolerant groups of healthy control subjects.
| Condition | Intervention |
|---|---|
|
Incretin Effect Insulin Resistance Type 2 Diabetes |
Other: Oral glucose tolerance test (OGTT) Other: Isoglycemic intravenous glucose infusion |
| Study Type: | Observational |
| Study Design: | Case Control, Cross-Sectional |
| Official Title: | The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects |
Blood samples
| Enrollment: | 32 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Obese patients with type 2 diabetes
Patients with type 2 diabetes and BMI>33
|
Other: Oral glucose tolerance test (OGTT) Other: Isoglycemic intravenous glucose infusion |
|
Obese subjects with normal glucose tolerance
Subjects with normal glucose tolerance and BMI>33
|
Other: Oral glucose tolerance test (OGTT) Other: Isoglycemic intravenous glucose infusion |
|
Lean subjects with type 2 diabetes
Patients with type 2 diabetes and BM<25
|
Other: Oral glucose tolerance test (OGTT) Other: Isoglycemic intravenous glucose infusion |
|
Lean subjects with normal glucose tolerance
Subjects with normal glucose tolerance and BM<25
|
Other: Oral glucose tolerance test (OGTT) Other: Isoglycemic intravenous glucose infusion |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Lean and obese patients with type 2 diabetes; and matched healthy control subjects.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | University Hospital, Gentofte, Copenhagen ( Dr. Filip K. Knop, MD PhD ) |
| Study ID Numbers: | BMI-INK |
| Study First Received: | December 4, 2008 |
| Last Updated: | December 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00803296 |
| Health Authority: | Denmark: National Board of Health |
|
Hyperinsulinism Obesity Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Healthy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin |
