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GLP-1 Infusion and Long-Time Fasting

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ClinicalTrials.gov Identifier: NCT00285896
Recruitment Status : Completed
First Posted : February 2, 2006
Last Update Posted : July 11, 2008
Sponsor:
Information provided by:
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Glucagon-like-peptide-1 (7-36) amide Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes 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.

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): NCT00285896


Locations
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Denmark
Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Ole E. Schmitz, Professor Department of pharmacology, Aarhus university
Study Director: Birgitte Brock, MD Department of Pharmacology ,University of Aarhus
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Ole E. Schmitz, University of Aarhus, department of Pharmacology
ClinicalTrials.gov Identifier: NCT00285896    
Other Study ID Numbers: 2004-0172
First Posted: February 2, 2006    Key Record Dates
Last Update Posted: July 11, 2008
Last Verified: July 2008
Keywords provided by University of Aarhus:
GLP-1
fasting
hypoglycaemia
Additional relevant MeSH terms:
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Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins