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

January 12, 2010 updated by: University Hospital, Gentofte, Copenhagen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Hellerup, Copenhagen, Denmark, 2900
        • Gentofte Hospital, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incretin effect
Time Frame: 2 days
2 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin resistance
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Investigators

  • Study Chair: Tina Vilsbøll, MD DMSc, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 4, 2008

First Submitted That Met QC Criteria

December 4, 2008

First Posted (Estimate)

December 5, 2008

Study Record Updates

Last Update Posted (Estimate)

January 13, 2010

Last Update Submitted That Met QC Criteria

January 12, 2010

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMI-INK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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