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NCT00638573 Clinical Trial

The Incretin Effect in Patients With Chronic Pancreatitis

Type 2 Diabetes Mellitus Clinical Trial

Official title:
The Incretin Effect in Patients With Chronic Pancreatitis With and Without Secondary Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00638573
Other study ID # KA04034
Secondary ID
Status Completed
Phase N/A
First received March 12, 2008
Last updated January 12, 2010
Start date January 2006
Est. completion date July 2006

Study information
Verified date March 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 phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a primary event leading to T2DM or if it is merely a consequence of the diabetic state. To answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.

Recruitment information / eligibility
Status Completed
Enrollment 32
Est. completion date July 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosis of chronic pancreatitis with secondary diabetes mellitus

- Diagnosis of chronic pancreatitis with normal glucose tolerance

- Diagnosis of type 2 diabetes

- Normal level of hemoglobin

- Normal level of se-creatinine

Exclusion Criteria:

- GAD-65 autoantibodies

- ICA autoantibodies

- Albuminuria

Study Design

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

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Gentofte University Hospital Hellerup Copenhagen County

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Gentofte, Copenhagen University of Copenhagen

Country where clinical trial is conducted

Denmark, 

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