Effects of Lipemia and Metformin on Endothelial Function

NCT01037660 | Completed Early Phase 1 FDA Drug

• 1 other identifier: H-23660
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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

Keywords

endothelium; cardiovascular disease; dietary fat; insulin resistance

Outcome Measures

Primary Outcomes (1)

• Brachial artery flow-mediated dilation

  6 hours

Secondary Outcomes (1)

• blood lipid levels

  6 hours

Study Arms (1)

Metformin

EXPERIMENTAL

Metformin

Drug: Metformin

Interventions

Metformin DRUG

Metformin 1 gram per day

Metformin

Eligibility Criteria

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

You may qualify if:

• Healthy volunteers

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Insulin Resistance

Interventions

Metformin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Naomi Hamburg, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 19, 2009
• First Posted: December 23, 2009
• Study Start: September 1, 2005
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 10, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)