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Glucagon-Like Peptide-1 (GLP-1) Suppression of Alpha Cell Secretion in Type 2 Diabetes Mellitus (T2DM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00862589
First Posted: March 17, 2009
Last Update Posted: March 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Copenhagen
Information provided by:
University Hospital, Gentofte, Copenhagen
  Purpose

The incretin hormone glucagon-like peptide-1 (GLP-1) has known insulinotrophic and glucagonostatic properties. However, inpatients with type 2 diabetes mellitus (T2DM)it is shown, that the beta cell sensitivity towards GLP-1 is decreased, when comparing to healthy controls. Further, these patients have decreased GLP-1 response to a meal.

The aim of this study is to elucidate if the diabetic hyperglucagonemia, seen in these patients both during fasting and in a postprandial condition, is coursed by a decreased sensitivity to GLP-1 in the diabetic alpha cell.

Ten T2DM patients and ten matched healthy control subjects will be examined on two separate days. Day 1: increasing GLP-1 infusions and Day 2: saline. During both days plasma glucose (PG) will be clamped at fasting level (FPG).

Patients with T2DM will be submitted til a Day 3, here PG will be normalized over-night by an adjustable insulin infusion, on the following day the GLP-1 infusion of Day 1 will be repeated.

The hypothesis is that these patients have decreased alpha cell sensitivity to GLP-1 as is the case with the beta cell sensitivity. This decreased sensitivity, the investigators speculate, contributes the defect suppression og glucagon and thereby to the increased PG levels seen in T2DM. Further the investigators will elucidate if this sensitivity can be increased by normalizing the diabetic PG to a normal FPG level.


Condition Intervention
Hyperglycemia Hyperglucagonemia Glucose Intolerance Other: GLP-1 infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: GLP-1 Suppression of Alpha Cell Secretion in T2DM

Resource links provided by NLM:


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

Primary Outcome Measures:
  • glucagon suppression

Enrollment: 20
Study Start Date: October 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: GLP-1 infusion
    physiological effect of GLP-1
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • T2DM according to WHO criteria
  • Written consent
  • Age > 18 years

Exclusion Criteria:

  • Kidney or hepatic disease
  • Treatment with insulin or glitazone
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kristine Hare/MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT00862589     History of Changes
Other Study ID Numbers: H-KA-20070023
First Submitted: March 13, 2009
First Posted: March 17, 2009
Last Update Posted: March 18, 2009
Last Verified: March 2009

Keywords provided by University Hospital, Gentofte, Copenhagen:
glucagon
GLP-1
hyperglycemia

Additional relevant MeSH terms:
Hyperglycemia
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins