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

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ClinicalTrials.gov Identifier: NCT00862589
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : March 18, 2009
Sponsor:
Collaborator:
University of Copenhagen
Information provided by:
University Hospital, Gentofte, Copenhagen

Brief Summary:

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 or disease Intervention/treatment Phase
Hyperglycemia Hyperglucagonemia Glucose Intolerance Other: GLP-1 infusion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: GLP-1 Suppression of Alpha Cell Secretion in T2DM
Study Start Date : October 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon
U.S. FDA Resources


Intervention Details:
    Other: GLP-1 infusion
    physiological effect of GLP-1


Primary Outcome Measures :
  1. glucagon suppression


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

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 Posted: March 17, 2009    Key Record Dates
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