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Effects of Lipemia and Metformin on Endothelial Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Naomi M Hamburg, Boston University
ClinicalTrials.gov Identifier:
NCT01037660
First received: December 19, 2009
Last updated: March 8, 2017
Last verified: March 2017
December 19, 2009
March 8, 2017
September 2005
December 1, 2015   (Final data collection date for primary outcome measure)
Brachial artery flow-mediated dilation [ Time Frame: 6 hours ]
Same as current
Complete list of historical versions of study NCT01037660 on ClinicalTrials.gov Archive Site
blood lipid levels [ Time Frame: 6 hours ]
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
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (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.
 
Completed
139
December 1, 2016
December 1, 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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01037660
H-23660
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
Plan to Share IPD: No
Naomi M Hamburg, Boston University
Boston University
Not Provided
Principal Investigator: Naomi Hamburg, MD Boston University
Boston University
March 2017

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