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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00803296
First received: December 4, 2008
Last updated: January 12, 2010
Last verified: December 2008

December 4, 2008
January 12, 2010
January 2006
January 2008   (final data collection date for primary outcome measure)
Incretin effect [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00803296 on ClinicalTrials.gov Archive Site
Insulin resistance [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Incretin Effect in Lean and Obese Subjects
The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood samples

Non-Probability Sample

Lean and obese patients with type 2 diabetes; and matched healthy control subjects.

  • Incretin Effect
  • Insulin Resistance
  • Type 2 Diabetes
  • Other: Oral glucose tolerance test (OGTT)
  • Other: Isoglycemic intravenous glucose infusion
  • Obese patients with type 2 diabetes
    Patients with type 2 diabetes and BMI>33
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Other: Oral glucose tolerance test (OGTT)
    • Other: Isoglycemic intravenous glucose infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2008
January 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00803296
BMI-INK
No
Dr. Filip K. Knop, MD PhD, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
Not Provided
Study Chair: Tina Vilsbøll, MD DMSc Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
University Hospital, Gentofte, Copenhagen
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP