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The Incretin Effect in Patients With Chronic Pancreatitis

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00638573
First received: March 12, 2008
Last updated: January 12, 2010
Last verified: March 2008
History of Changes
  Purpose

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.


Condition
Chronic Pancreatitis
Type 2 Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Incretin Effect in Patients With Chronic Pancreatitis With and Without Secondary Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

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

Biospecimen Retention:   Samples With DNA

Blood samples


Enrollment: 32
Study Start Date: January 2006
Estimated Study Completion Date: July 2006
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic pancreatitis with and without secondary diabetes mellitus

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638573

Locations
Denmark
Gentofte University Hospital
Hellerup, Copenhagen County, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
University of Copenhagen
Investigators
Principal Investigator: Filip K Knop, MD University of Copenhagen
Study Director: Jens J Holst, MD DMSc University of Copenhagen
Study Director: Thure Krarup, MD DMSc Gentofte University Hospital
  More Information

No publications provided

Responsible Party: Filip K. Knop, Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00638573     History of Changes
Other Study ID Numbers: KA04034
Study First Received: March 12, 2008
Last Updated: January 12, 2010
Health Authority: Denmark: National Board of Health

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

ClinicalTrials.gov processed this record on May 19, 2013