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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

December 19, 2009
July 15, 2014
September 2005
December 2015   (final data collection date for primary outcome measure)
Brachial artery flow-mediated dilation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01037660 on ClinicalTrials.gov Archive Site
blood lipid levels [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Lipemia and Metformin on Endothelial Function
Effects of Lipemia and Metformin on Endothelial Function

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Cardiovascular Disease
Drug: Metformin
Metformin 1 gram per day
Experimental: Metformin
Metformin
Intervention: Drug: Metformin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Joseph Vita, MD 617-638-8742 jvita@bu.edu
Contact: Monika Holbrook, MS 617-638-8748 monica.holbrook@bmc.org
United States
 
NCT01037660
H-23660
No
Joseph A. Vita, Boston University
Boston University
Not Provided
Principal Investigator: Joseph A Vita, MD Boston University
Boston University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP