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NCT00803296 Clinical Trial

Incretin Effect in Lean and Obese Subjects

Type 2 Diabetes Clinical Trial

— BMI-INK  

Official title:
The Impact of Obesity and Insulin Resistance on the Incretin Effect in Patients With Type 2 Diabetes and Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00803296
Other study ID # BMI-INK
Secondary ID
Status Completed
Phase N/A
First received December 4, 2008
Last updated January 12, 2010
Start date January 2006
Est. completion date June 2008

Study information
Verified date December 2008
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date June 2008
Est. primary completion date January 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Other:
• Oral glucose tolerance test (OGTT)

• Isoglycemic intravenous glucose infusion

Locations
Country Name City State
Denmark Gentofte Hospital, University of Copenhagen Hellerup Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incretin effect 2 days No
Secondary Insulin resistance 2 days No
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