Effects of Lipemia and Metformin on Endothelial Function
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | September 2005 |
| End Date: | December 2015 |
| Contact: | Joseph Vita, MD |
| Email: | jvita@bu.edu |
| Phone: | 617-638-8742 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
