Effects of Lipemia and Metformin on Endothelial Function

Early Phase 1

Completed

• Conditions: Cardiovascular Disease
• Interventions: Drug: Metformin

• Registration Number: NCT01037660
• Lead Sponsor: Boston University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2009-12-19
• Study First Submitted QC: 2009-12-21
• Study First Posted: 2009-12-23
• Primary Completion: 2015-12-01
• Study Completion: 2016-12-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-08
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	Metformin

Primary Outcome Measures

Name	Time	Method
Brachial artery flow-mediated dilation	6 hours

Secondary Outcome Measures

Name	Time	Method
blood lipid levels	6 hours

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States