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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

NCT ID: NCT01689051

Last Updated: 2014-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Blod Pressure Glucagon-like Peptide-1 Human Physiology Blood Flow

Keywords

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Type 2 diabetes Blod pressure Glucagon-like peptide-1 Human physiology Blood flow

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy subjects

Group Type ACTIVE_COMPARATOR

human glucagon-like peptide 1 (7-36)amide

Intervention Type OTHER

human glucagon-like peptide 1 (9-36)amide

Intervention Type OTHER

Patients with type 2 diabetes

Group Type ACTIVE_COMPARATOR

human glucagon-like peptide 1 (7-36)amide

Intervention Type OTHER

human glucagon-like peptide 1 (9-36)amide

Intervention Type OTHER

Interventions

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human glucagon-like peptide 1 (7-36)amide

Intervention Type OTHER

human glucagon-like peptide 1 (9-36)amide

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Danish Heart Foundation

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jacob Christian Sivertsen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacob C Sivertsen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Locations

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Gentofte Hospital, Department of Cardiology

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-Sivertsen

Identifier Type: -

Identifier Source: org_study_id