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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:
ClinicalTrials.gov Identifier:
NCT01689051
First Posted: September 20, 2012
Last Update Posted: January 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Danish Heart Foundation
Information provided by (Responsible Party):
Jacob Christian Sivertsen, University Hospital, Gentofte, Copenhagen
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by Jacob Christian Sivertsen, University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Femoral artery blood flow

Secondary Outcome Measures:
  • Leg glucose uptake

Enrollment: 20
Study Start Date: March 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Healthy subjects 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 Other: human glucagon-like peptide 1 (7-36)amide Other: human glucagon-like peptide 1 (9-36)amide

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689051


Locations
Denmark
Gentofte Hospital, Department of Cardiology
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Danish Heart Foundation
Investigators
Principal Investigator: Jacob C Sivertsen, MD University Hospital, Gentofte, Copenhagen
  More Information

Responsible Party: Jacob Christian Sivertsen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01689051     History of Changes
Other Study ID Numbers: 1-Sivertsen
First Submitted: September 17, 2012
First Posted: September 20, 2012
Last Update Posted: January 31, 2014
Last Verified: January 2014

Keywords provided by Jacob Christian Sivertsen, University Hospital, Gentofte, Copenhagen:
Type 2 diabetes
Blod pressure
Glucagon-like peptide-1
Human physiology
Blood flow

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins