Clinical trial NCT00285896: GLP-1 Infusion and Long-Time Fasting
Official title: The Effect of 48 Hours of GLP-1 Infusion During Long-Time Fasting on Glycaemia and Counterregulatory Hormones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: GLP-1
fasting
hypoglycaemia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 8
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital
Study officials:
affiliation: Department of pharmacology, Aarhus university
name: Ole E. Schmitz, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pharmacology ,University of Aarhus
name: Birgitte Brock, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1111/j.1365-2265.2008.03510.x. Epub 2008 Dec 15.