Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Jacob Christian Sivertsen, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01689051
First received: September 17, 2012
Last updated: January 30, 2014
Last verified: January 2014

September 17, 2012
January 30, 2014
March 2012
April 2013   (final data collection date for primary outcome measure)
Femoral artery blood flow [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01689051 on ClinicalTrials.gov Archive Site
Leg glucose uptake [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus
Not Provided

Diabetes and high blood pressure are risk factors for developing heart disease. An increase in the number of diabetes patients is expected. This increases the number of patients with heart disease, and since the vast majority with diabetes die from heart disease, it is extremely important to investigate how these diseases can be prevented and treated.

Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can expand blood vessels, thus lowering blood pressure, but it is not known whether the effects is found in humans, which we will investigate.

Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1 has an effect on the muscles which increases the uptake of sugar. We investigate whether GLP-1 enhances the absorption of sugar in the leg.

The investigators also examines whether these effects are greater in people with diabetes then in healthy.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
  • Type 2 Diabetes
  • Blod Pressure
  • Glucagon-like Peptide-1
  • Human Physiology
  • Blood Flow
  • Other: human glucagon-like peptide 1 (7-36)amide
  • Other: human glucagon-like peptide 1 (9-36)amide
  • Active Comparator: Healthy subjects
    Interventions:
    • Other: human glucagon-like peptide 1 (7-36)amide
    • Other: human glucagon-like peptide 1 (9-36)amide
  • Active Comparator: Patients with type 2 diabetes
    Interventions:
    • Other: human glucagon-like peptide 1 (7-36)amide
    • Other: human glucagon-like peptide 1 (9-36)amide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent
  • T2DM according to WHO's criteria (only T2DM subjects)

Exclusion Criteria:

  • Anemia
  • T1DM
  • Severe liver or renal disease
  • Severe heart disease
  • Atrial fibrillation
Male
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01689051
1-Sivertsen
No
Jacob Christian Sivertsen, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
Danish Heart Foundation
Principal Investigator: Jacob C Sivertsen, MD University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP