The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes

This study has been completed.

First Received: August 11, 2008 Last Updated: February 12, 2009 History of Changes

Sponsors and Collaborators:	University Hospital, Gentofte, Copenhagen University of Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00732602

Purpose

The purpose of this study is to determine whether Glucose-dependent Insulinotropic Polypeptide (GIP) or Glucagon Like Peptide 2 (GLP-2) has an affect on the secretion of Glucagon from the pancreas in patients with type 1 diabetes mellitus.

Condition	Intervention
Diabetes Mellitus	Other: GIP-infusion Other: Sodium-chloride Other: GLP-2 infusion

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment
Official Title:	The Effects of GIP and GLP-2 on the Secretion of Glucagon in Patients With Type 1 Diabetes

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Chlorides Glucagon Sodium chloride

U.S. FDA Resources

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

Primary Outcome Measures:

plasma-glucagon Area Under Curve at 0-90 min. and 90-180 min. [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	January 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Active Comparator GLP-2 infusion	Other: GLP-2 infusion
C: Placebo Comparator Sodium-chloride infusion	Other: Sodium-chloride
A: Active Comparator GIP-infusion	Other: GIP-infusion

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Caucasians over 18 years with type 1 diabetes (WHO criteria)
Arginine test without rise in plasma C-peptide
Normal blood Hemoglobin
Informed consent

Exclusion Criteria:

Liver disease
Diabetic nephropathy
Treatment with medications unpausable for 12 hours

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00732602

Locations

Denmark, Capital Region
University Hospital, Gentofte
Hellerup, Capital Region, Denmark, 2900

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

University of Copenhagen

More Information

No publications provided

Responsible Party:	University Hospital, Gentofte, Copenhagen ( Mikkel Christensen MD )
Study ID Numbers:	H-D-2007-0058
Study First Received:	August 11, 2008
Last Updated:	February 12, 2009
ClinicalTrials.gov Identifier:	NCT00732602 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by University Hospital, Gentofte, Copenhagen:

Glucagon
Glucose-dependent Insulinotropic Polypeptide
Glucagon-Like peptide 2

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Gastric Inhibitory Polypeptide
Hormone Antagonists
Glucagon
Diabetes Mellitus
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases

Diabetes Mellitus Type 1
Hormones
Diabetes Mellitus, Type 1
Incretins
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Autoimmune Diseases
Gastric Inhibitory Polypeptide
Immune System Diseases
Glucagon
Physiological Effects of Drugs
Gastrointestinal Agents
Diabetes Mellitus

Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Hormones
Pharmacologic Actions
Diabetes Mellitus, Type 1
Therapeutic Uses
Incretins
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on August 25, 2009