GLP-1 Infusion and Long-Time Fasting - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00285896

Purpose

GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion in a glucose dependent way. Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two conditions.

Condition	Intervention
Type 2 Diabetes	Drug: Glucagon-like-peptide-1 (7-36) amide Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
Official Title:	The Effect of 48 Hours of GLP-1 Infusion During Long-Time Fasting on Glycaemia and Counterregulatory Hormones

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Glucagon Glucagon-like peptide 1

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Area under curve (AUC)for plasma glucose, insulin, insulin secretion velocity and glucagon for the periods 0-48 hours(day 1-2) and 0-180 min (day 3). And also the lowest plasma glucose during the period 0-180 min day 3 and mean blood pressure [ Time Frame: measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3) ] [ Designated as safety issue: Yes ]

Enrollment:	8
Study Start Date:	December 2005
Study Completion Date:	May 2007
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Active Comparator GLP-1	Drug: Glucagon-like-peptide-1 (7-36) amide Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours
Placebo: Placebo Comparator Placebo	Drug: Placebo continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours

Detailed Description:

GLP-1 is an incretin hormone that simulates insulin secretion and inhibits glucagon secretion dependent on a normal plasma glucose.It also inhibits gastric emptying and has a trophic effect on the pancreatic beta-cells.

Below normal plasma glucose levels the effects of GLP-1 stop and the risk of hypoglycemia is small.The counter regulatory response to hypoglycemia has been shown to be preserved during GLP-1 infusion. However no results exits on the effects pharmacologically relevant doses of GLP-1 during long-time fasting. There seems to be a risk of hypoglycemia in healthy people after a fasting period when a glucose load is administered. The risk of hypoglycemia when GLP-1 is administered will be evaluated during these two(48 hours of fasting followed by a glucose-load)conditions in healthy men. Also the effect on 24 hour blood pressure will be evaluated.

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy male, age 20-50 years, BMI 20-30 kg/m2, Blood pressure < 140/90 mmHg, caucasian.

Exclusion Criteria:

Diabetes in relatives, anaemia, any significant disease, smoking.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285896

Locations

Denmark
Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:	Ole E. Schmitz, Professor	Department of pharmacology, Aarhus university
Study Director:	Birgitte Brock, MD	Department of Pharmacology ,University of Aarhus

More Information

No publications provided

Responsible Party:	University of Aarhus, department of Pharmacology ( Professor Ole E. Schmitz )
Study ID Numbers:	2004-0172
Study First Received:	February 1, 2006
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00285896 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by University of Aarhus:

GLP-1
fasting
hypoglycaemia

Study placed in the following topic categories:

Metabolic Diseases
Hormone Antagonists
Glucagon
Diabetes Mellitus
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Hypoglycemia

Hormones
Glucagon-Like Peptide 1
Diabetes Mellitus, Type 2
Incretins
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Hormones
Pharmacologic Actions
Glucagon-Like Peptide 1

ClinicalTrials.gov processed this record on August 30, 2009