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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:
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
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Femoral artery blood flow [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Leg glucose uptake [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jacob Christian Sivertsen, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01689051     History of Changes
Other Study ID Numbers: 1-Sivertsen
Study First Received: September 17, 2012
Last Updated: January 30, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on November 25, 2014