- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01689051
Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hellerup, Denmark, 2900
- Gentofte Hospital, Department of Cardiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy subjects
|
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Active Comparator: Patients with type 2 diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Femoral artery blood flow
|
Secondary Outcome Measures
Outcome Measure |
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Leg glucose uptake
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jacob C Sivertsen, MD, University Hospital, Gentofte, Copenhagen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-Sivertsen
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