The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia

NCT00418288 | Completed

• 1 other identifier: 2005-0089
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New animal studies indicate a protective effect of GLP-1 in the brain and the heart. The mechanism behind this is yet not known. The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert protective effects in the brain.

Conditions

Type 2 Diabetes; Stroke; Myocardial Infarction

Keywords

GLP-1; glucose metabolism; Type 2 diabetes; brain; PET

Outcome Measures

Primary Outcomes (2)

• The acute effect of GLP-1 on glucose uptake in the brain

  1 hour

• The acute effect of GLP-1 on glucose uptake in the heart

  1 hour

Secondary Outcomes (3)

• The acute effect of GLP-1 on glucose metabolic rate in the brain

  1 hour

• The acute effect of GLP-1 on intracerebral glucose concentration

  1 hour

• The acute effect of GLP-1 on lumped constant in the brain

  1 hour

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: glucagon-like-peptide-1

P

PLACEBO COMPARATOR

Drug: placebo

Interventions

glucagon-like-peptide-1 DRUG

intravenous infusion of 1.2pmol/kg/min for 7 hours

A

placebo DRUG

intravenous infusion of 1.2pmol/kg/min

P

Eligibility Criteria

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

You may qualify if:

• Healthy men
• Age 20-50 years
• Caucasian
• BMI 20-30 kg/m2

You may not qualify if:

• Diabetes in subject and 1.degree relatives
• Any disease of clinical relevance

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of pharmacology, Aarhus university

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Gejl M, Lerche S, Mengel A, Moller N, Bibby BM, Smidt K, Brock B, Sondergaard H, Botker HE, Gjedde A, Holst JJ, Hansen SB, Rungby J. Influence of GLP-1 on myocardial glucose metabolism in healthy men during normo- or hypoglycemia. PLoS One. 2014 Jan 6;9(1):e83758. doi: 10.1371/journal.pone.0083758. eCollection 2014.

  PMID: 24400077 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Stroke; Myocardial Infarction

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ole E Schmitz, MD, DSc

  Department of pharmacology, Aarhus university

  PRINCIPAL INVESTIGATOR

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: January 3, 2007
• First Posted: January 4, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: February 1, 2008
• Last Updated: June 10, 2008

Record last verified: 2008-06

Locations

DK (1)