GLP-1 Infusion and Long-Time Fasting

NCT00285896 | Completed DMC

• 1 other identifier: 2004-0172
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

GLP-1; fasting; hypoglycaemia

Outcome Measures

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

  measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)

Study Arms (2)

Active

ACTIVE COMPARATOR

GLP-1

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

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

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

Also known as: GLP-1

Active

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 19094067 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Fasting; Hypoglycemia

Interventions

glucagon-like peptide 1 (7-36)amide; Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Ole E. Schmitz, Professor

  Department of pharmacology, Aarhus university

  PRINCIPAL INVESTIGATOR

• Birgitte Brock, MD

  Department of Pharmacology ,University of Aarhus

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 2, 2006
• Study Start: December 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: July 11, 2008

Record last verified: 2008-07

Locations

DK (1)