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CompletedNCT00285896Updated Jul 11, 2008

GLP-1 Infusion and Long-Time Fasting

An interventional study of Glucagon-like-peptide-1 (7-36) amide and Placebo in Type 2 Diabetes, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to male participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-11.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • GLP-1
  • fasting
  • hypoglycaemia
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • healthy male, age 20-50 years, BMI 20-30 kg/m2, Blood pressure \< 140/90 mmHg, caucasian.

Exclusion criteria

Exclusion Criteria:

  • Diabetes in relatives, anaemia, any significant disease, smoking.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
8 participants (actual)

Study arms

  • Active comparator
    Active

    GLP-1

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

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • DrugGlucagon-like-peptide-1 (7-36) amide

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

    Also known as: GLP-1

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. 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)

07

Study locations

1 site
  • Department of pharmacology, Aarhus university and Medical department M, Aarhus University hospital
    Aarhus, 8000, Denmark
08

References and documents

Publications

  • 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. PubMed 19094067 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00285896
Lead sponsor
University of Aarhus
First posted
Feb 2, 2006
Start date
Dec 2005
Primary completion
Oct 2006
Completion
May 2007
Last update
Jul 11, 2008

Study contacts

Ole E. Schmitz, Professor
principal investigator · Department of pharmacology, Aarhus university
Birgitte Brock, MD
study director · Department of Pharmacology ,University of Aarhus

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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