GLP-1 Infusion and Long-Time Fasting

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Glucagon-like-peptide-1 (7-36) amide; Drug: Placebo

• Registration Number: NCT00285896
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-01
• Study First Posted: 2006-02-02
• Primary Completion: 2006-10
• Study Completion: 2007-05
• Status Verified: 2008-07
• Last Update Submitted: 2008-07-10
• Last Update Posted: 2008-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active	Glucagon-like-peptide-1 (7-36) amide	GLP-1
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
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	measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)

Trial Locations

Locations (1)

Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital; 🇩🇰 Aarhus, Denmark