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

NCT01689051 | Completed

• 1 other identifier: 1-Sivertsen
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Femoral artery blood flow

Secondary Outcomes (1)

• Leg glucose uptake

Study Arms (2)

Healthy subjects

ACTIVE COMPARATOR

Other: human glucagon-like peptide 1 (7-36)amide; Other: human glucagon-like peptide 1 (9-36)amide

Patients with type 2 diabetes

ACTIVE COMPARATOR

Other: human glucagon-like peptide 1 (7-36)amide; Other: human glucagon-like peptide 1 (9-36)amide

Interventions

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

Healthy subjects; Patients with type 2 diabetes

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

Healthy subjects; Patients with type 2 diabetes

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• T2DM according to WHO's criteria (only T2DM subjects)

You may not qualify if:

• Anemia
• T1DM
• Severe liver or renal disease
• Severe heart disease
• Atrial fibrillation

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Danish Heart Foundation: collaborator

Study Sites (1)

Gentofte Hospital, Department of Cardiology

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jacob C Sivertsen, MD

  University Hospital, Gentofte, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 20, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

DK (1)