Effects of Lipemia and Metformin on Endothelial Function

Boston University

Status and phase

Completed

Early Phase 1

Conditions

Cardiovascular Disease

Treatments

Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT01037660

H-23660

Details and patient eligibility

About

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.

Enrollment

139 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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