search
Back to results

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

Primary Purpose

Type 2 Diabetes, Blod Pressure, Glucagon-like Peptide-1

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
human glucagon-like peptide 1 (7-36)amide
human glucagon-like peptide 1 (9-36)amide
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Blod pressure, Glucagon-like peptide-1, Human physiology, Blood flow

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Gentofte Hospital, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Healthy subjects

Patients with type 2 diabetes

Arm Description

Outcomes

Primary Outcome Measures

Femoral artery blood flow

Secondary Outcome Measures

Leg glucose uptake

Full Information

First Posted
September 17, 2012
Last Updated
January 30, 2014
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Danish Heart Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01689051
Brief Title
Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Danish Heart Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Blod Pressure, Glucagon-like Peptide-1, Human Physiology, Blood Flow
Keywords
Type 2 diabetes, Blod pressure, Glucagon-like peptide-1, Human physiology, Blood flow

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subjects
Arm Type
Active Comparator
Arm Title
Patients with type 2 diabetes
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
human glucagon-like peptide 1 (7-36)amide
Intervention Type
Other
Intervention Name(s)
human glucagon-like peptide 1 (9-36)amide
Primary Outcome Measure Information:
Title
Femoral artery blood flow
Secondary Outcome Measure Information:
Title
Leg glucose uptake

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob C Sivertsen, MD
Organizational Affiliation
University Hospital, Gentofte, Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital, Department of Cardiology
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs