Effects of Lipemia and Metformin on Endothelial Function

NCT ID: NCT01037660

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2016-12-01

Brief Summary

Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the arteries). Acute fat consumption increases levels of fat in the blood and temporarily reduces the ability of blood vessel to dilate (open up to carry additional blood). A similar response is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition). The present study is designed to help us understand the effects of a fat load on blood vessel function. We will measure arterial dilation using non-invasive techniques before and at the end of a 5-hour infusion of Intra-Lipid in healthy subjects. Subjects will then take the approved drug metformin for two weeks and return for repeat studies of endothelial function with Intra-Lipid infusion. We expect that metformin will help preserve the normal function of blood vessels during a fat load. This study will help us understand how fat affects blood vessels and therefore will advance our knowledge of the development of atherosclerosis and potentially lead to improved methods to prevent and treat heart disease.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Metformin

Metformin

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Metformin 1 gram per day

Interventions

Metformin

Metformin 1 gram per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers

Exclusion Criteria

• Pregnancy (defined as positive urine pregnancy test)
• Diabetes Mellitus (Clinical history or random blood glucose>140 mg/dl)
• Hypertension (Clinical history or SBP>140 or DBP>90 mmHg)
• History of adverse reaction to metformin
• Abnormal renal function (Serum creatinine>1.4 mg/dl)
• Abnormal liver function (AST or ALT greater than two times the upper limit of normal)
• Administration of iodinated contrast within 7 days
• History of congestive heart failure
• Abnormal clotting parameters (INR>1.5 or PTT>40 sec)
• Anemia (HCT<30%)
• Allergy to soy or egg
• Allergy to heparin
• The potential subject plans to perform heavy exercise in the setting of low calorie intake during the period of the study such as running or competitive road or bicycle racing

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Naomi M Hamburg

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Naomi Hamburg, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-23660

Identifier Type: -

Identifier Source: org_study_id