GLP-1 Infusion and Long-Time Fasting

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of 48 Hours of GLP-1 Infusion During Long-Time Fasting on Glycaemia and Counterregulatory Hormones

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Glucagon-like-peptide-1 (7-36) amide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>GLP-1 | Drug: Glucagon-like-peptide-1 (7-36) amide<br>* Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours<br>* Other names: GLP-1;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GLP-1, fasting, hypoglycaemia