Effects of Lipemia and Metformin on Endothelial Function

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Boston University
Sponsor:
Information provided by (Responsible Party):
Joseph A. Vita, Boston University
ClinicalTrials.gov Identifier:
NCT01037660
First received: December 19, 2009
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Drug: Metformin

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Lipemia and Metformin on Endothelial Function

Resource links provided by NLM:


Further study details as provided by Boston University:

Primary Outcome Measures:
  • Brachial artery flow-mediated dilation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood lipid levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: September 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin
Metformin
Drug: Metformin
Metformin 1 gram per day

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037660

Contacts
Contact: Joseph Vita, MD 617-638-8742 jvita@bu.edu
Contact: Monika Holbrook, MS 617-638-8748 monica.holbrook@bmc.org

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Joseph A Vita, MD    617-638-8701    jvita@bu.edu   
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: Joseph A Vita, MD Boston University
  More Information

No publications provided

Responsible Party: Joseph A. Vita, Professor of Medicine, Boston University
ClinicalTrials.gov Identifier: NCT01037660     History of Changes
Other Study ID Numbers: H-23660
Study First Received: December 19, 2009
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston University:
endothelium
cardiovascular disease
dietary fat
insulin resistance

Additional relevant MeSH terms:
Cardiovascular Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014