Effects of Lipemia and Metformin on Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01037660
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Naomi M Hamburg, 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Drug: Metformin Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Lipemia and Metformin on Endothelial Function
Actual Study Start Date : September 2005
Primary Completion Date : December 1, 2015
Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Metformin
Drug: Metformin
Metformin 1 gram per day

Primary Outcome Measures :
  1. Brachial artery flow-mediated dilation [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. blood lipid levels [ Time Frame: 6 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01037660

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Principal Investigator: Naomi Hamburg, MD Boston University

Responsible Party: Naomi M Hamburg, PI, Boston University Identifier: NCT01037660     History of Changes
Other Study ID Numbers: H-23660
First Posted: December 23, 2009    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Naomi M Hamburg, Boston University:
cardiovascular disease
dietary fat
insulin resistance

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