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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
History of Changes
  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:

Drug Information available for: Dextrose
U.S. FDA Resources

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

Primary Outcome Measures:
  • Incretin effect [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 4, 2008
Last Updated: January 12, 2010
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 19, 2013