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

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT01689051
• Collaborator: Danish Heart Foundation (Other)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Femoral artery blood flow []

Secondary Outcome Measures

1. Leg glucose uptake []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jacob Christian Sivertsen, MD, University Hospital, Gentofte, Copenhagen
• ClinicalTrials.gov Identifier: NCT01689051
• Other Study ID Numbers: 1-Sivertsen
• First Posted: Sep 20, 2012
• Last Update Posted: Jan 31, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Jacob Christian Sivertsen, MD, 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; Glucagon; Glucagon-Like Peptide 1

Study Results

No Results Posted as of Jan 31, 2014