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Incretin Effect in Lean and Obese Subjects (BMI-INK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00803296
First Posted: December 5, 2008
Last Update Posted: January 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Gentofte, Copenhagen
  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: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Incretin effect [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: 2 days ]

Biospecimen Retention:   Samples With DNA
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Lean and obese patients with type 2 diabetes; and matched healthy control subjects.
Criteria

Inclusion Criteria:

  • Diagnosed with type 2 diabetes for at least 3 months
  • Normal blood hemoglobin
  • Informed consent

Exclusion Criteria:

  • Liver disease
  • Diabetic nephropathy
  • Treatment with medication that can not be stopped for 12 hours
  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): NCT00803296


Locations
Denmark
Gentofte Hospital, University of Copenhagen
Hellerup, Copenhagen, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Investigators
Study Chair: Tina Vilsbøll, MD DMSc Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
  More Information

Responsible Party: Dr. Filip K. Knop, MD PhD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00803296     History of Changes
Other Study ID Numbers: BMI-INK
First Submitted: December 4, 2008
First Posted: December 5, 2008
Last Update Posted: January 13, 2010
Last Verified: December 2008

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs