GLP-1 Infusion and Long-Time Fasting

University of Aarhus8 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Type 2 Diabetes

Interventions

Glucagon-like-peptide-1 (7-36) amideDRUG

Continuous, subcutaneous GLP-1 at a dose of 4.8 pmol/kg/min for 51 hours

PlaceboDRUG

continuous subcutaneous placebo infusion at a dose of 4.8 pmol/kg/min for 51 hours

Eligibility

Sex: MALEMin age: 20 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

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)

Data from ClinicalTrials.gov

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