Effects of Lipemia and Metformin on Endothelial Function
Overview[ - collapse ][ - ]
| 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 | Cardiovascular Disease |
| Intervention | Drug: Metformin |
| Phase | N/A |
| Sponsor | Boston University |
| Responsible Party | Boston University |
| ClinicalTrials.gov Identifier | NCT01037660 |
| First Received | December 19, 2009 |
| Last Updated | July 23, 2013 |
| Last verified | July 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 19, 2009 |
|---|---|
| Last Updated Date | July 23, 2013 |
| Start Date | September 2005 |
| Estimated Primary Completion Date | December 2013 |
| Current Primary Outcome Measures | Brachial artery flow-mediated dilation [Time Frame: 6 hours] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | blood lipid levels [Time Frame: 6 hours] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effects of Lipemia and Metformin on Endothelial Function |
|---|---|
| Official Title | Effects of Lipemia and Metformin on Endothelial Function |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science |
| Condition | Cardiovascular Disease |
| Intervention | Drug: Metformin Metformin 1 gram per day |
| Study Arm (s) | Experimental: Metformin Metformin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 45 |
| Estimated Completion Date | December 2013 |
| Estimated Primary Completion Date | December 2013 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Contact: Joseph Vita, MD 617-638-8742 jvita@bu.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01037660 |
|---|---|
| Other Study ID Numbers | H-23660 |
| Has Data Monitoring Committee | No |
| Information Provided By | Boston University |
| Study Sponsor | Boston University |
| Collaborators | Not Provided |
| Investigators | Principal Investigator: Joseph A Vita, MD Boston University |
| Verification Date | July 2013 |
Locations[ + expand ][ + ]
| Boston Medical Center | Boston, Massachusetts, United States, 02118 Contact: Joseph A Vita, MD | 617-638-8701 | jvita@bu.eduRecruiting |
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