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GIP, GLP-1 and GLP-2 in Type 2 Diabetic Hyperglucagonemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00716170
First Posted: July 16, 2008
Last Update Posted: November 28, 2013
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.
Collaborators:
University of Copenhagen
The Danish Medical Research Council
The Danish Diabetes Association
Information provided by (Responsible Party):
Asger Lund, Herlev Hospital
  Purpose
In order to investigate the mechanisms underlying the hyperglucagonemia characterizing patients with type 2 diabetes mellitus (T2DM) we wish to test the following hypothesis: Do pancreatic alpha-cells exhibit inappropriate glucagon responses to substances released from the small intestine (GIP, GLP-2 and GLP-2) in patients with T2DM?

Condition Intervention
Type 2 Diabetes Mellitus Biological: Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1) and glucagon-like peptide-2 (GLP-2)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Role of GIP, GLP-1 and GLP-2 in Type 2 Diabetic Hyperglucagonemia

Resource links provided by NLM:


Further study details as provided by Asger Lund, Herlev Hospital:

Primary Outcome Measures:
  • Plasma glucagon responses [ Time Frame: 3 hours ]

Biospecimen Retention:   Samples With DNA
Blood plasma and leucocytes

Enrollment: 10
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A:
Patients with type 2 diabetes mellitus
Biological: Glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1) and glucagon-like peptide-2 (GLP-2)

Day A: Oral glucose tolerance test (50g glucose)

Day B: Isoglycemic intravenous (iv) glucose infusion

Day C: Isoglycemic iv glucose infusion + iv GIP infusion (0-20 min: 4 pmol/kg body weight/min; 20-50 min: 2 pmol/kg body weight/min)

Day D: Isoglycemic iv glucose infusion + iv GLP-1 infusion (0-20 min: 0,6 pmol/kg body weight/min; 20-50 min: 0,3 pmol/kg body weight/min)

Day E: Isoglycemic iv glucose infusion + iv GLP-2 infusion (0-20 min: 1 pmol/kg body weight/min; 20-50 min: 0,5 pmol/kg body wight/min)

Day F: Isoglycemic iv glucose infusion + iv infusion of GIP, GLP-1 and GLP-2 in doses as Day C, D and E.

Other Names:
  • Human GIP (glucose-dependent insulinotropic polypeptide)
  • Human GLP-1 (glucagon-like peptide-1)
  • Human GLP-2 (glucagon-like peptide-2)

Detailed Description:

Patients with T2DM are not able to suppress their secretion of glucagon after a meal or after oral ingestion of glucose. Patients actually respond with pathological high plasmaglucagon concentrations to these stimuli. Previous studies have shown that postprandial hyperglucagonemia results in increased hepatic glucose production and therefore contributes significantly to the hyperglycemia characterizing these patients.

Recently we have shown that patients with T2DM exhibit a normal suppression of glucagon secretion following an adjustable intravenous (iv) glucose challenge mimicking the glucose excursion following a 50-g oral glucose tolerance test (OGTT) with the latter resulting in lack of glucagon suppression. Why this difference? A possible explanation could be that the oral administration stimulates intestinal factors resulting in a differentially glucagon response to the two similar glucose excursions. We wish to establish whether GIP, GLP-1 and/or GLP-2 are responsible for the inappropriate glucagon suppression following OGTT and meals in patients with T2DM.

  Eligibility

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients will be recruted from the outpatient clinic of Department of Endocrinology, Herlev Hospital.
Criteria

Inclusion Criteria:

  • Caucasians with diet and/or tablet treated T2DM of at least 3 months duration (diagnosed according to the criterias of the World Health Organization (WHO))
  • Normal Hemoglobin
  • Prior Informed Consent

Exclusion Criteria:

  • Liver disease (ALAT/ASAT > 2 x upper normal value)
  • Diabetic nephropathy (se-creatinin > 130 um and/or albuminuria
  • Treatment with drugs that cannot be discontinued for 12 hours
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00716170


Locations
Denmark
Department of Endocrinology J, Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Herlev Hospital
University of Copenhagen
The Danish Medical Research Council
The Danish Diabetes Association
Investigators
Study Chair: Tina Vilsbøll, MD DMSc Herlev Hospital
Study Director: Filip K Knop, MD PhD Gentofte Hospital
  More Information

Publications:

Responsible Party: Asger Lund, MD, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00716170     History of Changes
Other Study ID Numbers: 1301831410
First Submitted: July 10, 2008
First Posted: July 16, 2008
Last Update Posted: November 28, 2013
Last Verified: April 2009

Keywords provided by Asger Lund, Herlev Hospital:
Diabetes Mellitus
Glucagon
Insulin
Incretin hormones
Glucose-dependent insulinotropic polypeptide
Glucagon-like peptide-1
Glucagon-like peptide-2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Gastric Inhibitory Polypeptide
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins