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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:
Collaborator:
University of Copenhagen
Information provided by:
University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT00862589
First received: March 13, 2009
Last updated: March 17, 2009
Last verified: March 2009
History of Changes
  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 Blind (Subject)
Official Title: GLP-1 Suppression of Alpha Cell Secretion in T2DM

Resource links provided by NLM:

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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

No publications provided by University Hospital, Gentofte, Copenhagen

Additional 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
Study First Received: March 13, 2009
Last Updated: March 17, 2009
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Hyperglycemia
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
 Glucagon-Like Peptide 1
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on May 19, 2013