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GLP-1 Infusion and Long-Time Fasting

NCT ID: NCT00285896

Last Updated: 2008-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-05-31

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.

Conditions

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Type 2 Diabetes

Keywords

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GLP-1 fasting hypoglycaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

GLP-1

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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GLP-1

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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University of Aarhus, department of Pharmacology

Principal Investigators

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Ole E. Schmitz, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of pharmacology, Aarhus university

Birgitte Brock, MD

Role: STUDY_DIRECTOR

Department of Pharmacology ,University of Aarhus

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 19094067 (View on PubMed)

Other Identifiers

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2004-0172

Identifier Type: -

Identifier Source: org_study_id