GLP-1 Infusion and Long-Time Fasting

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00285896
First received: February 1, 2006
Last updated: July 10, 2008
Last verified: July 2008
  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:


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):
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 April 17, 2014