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

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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Glucagon

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 Comparator: Active 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 Other Name: GLP-1
Placebo Comparator: Placebo Placebo	Drug: Placebo continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours Other Name: Placebo

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 by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lerche S, Soendergaard L, Rungby J, Moeller N, Holst JJ, Schmitz OE, Brock B. No increased risk of hypoglycaemic episodes during 48 h of subcutaneous glucagon-like-peptide-1 administration in fasting healthy subjects. Clin Endocrinol (Oxf). 2009 Oct;71(4):500-6. Epub 2008 Dec 15.

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

Keywords provided by University of Aarhus:

GLP-1
fasting
hypoglycaemia

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2
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 16, 2013