Status:
COMPLETED
Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Dyslipidemias
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study looks at whether niacin improves reverse cholesterol transport (RCT) in healthy volunteers. 3H-Cholesterol will be used to measure RCT by analyzing changes in the tracer activity in total p...
Detailed Description
The study will use 3H-cholesterol bound to albumin (particulate cholesterol) to assess the ability of high density lipoprotein (HDL) to transport cholesterol to the liver to be eliminated. This proces...
Eligibility Criteria
Inclusion
- Men and women between the ages of 18 and 75 inclusive
- HDL cholesterol \>= 25 mg/dL in all subjects, and \<= 60 mg/dL in men and \<= 70 mg/dL in women
- Women must be of non-childbearing potential. They must have been surgically sterilized at least 6 months prior to screening or be postmenopausal. Postmenopausal women must have no regular menstrual bleeding for at least 2 years prior to inclusion.
- Subjects must be in good overall health.
- Subjects must be able to comprehend and willing to provide a signed Institutional Regulatory Board (IRB) approved Informed Consent Form.
- Subjects must be willing to comply with all study-related procedures.
- Subjects must weigh at least 140 pounds to participate in the HDL kinetics Substudy.
Exclusion
- Clinically-manifest cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
- History of diabetes mellitus or fasting glucose \> 126 mg/dL at the screening visit
- Presence of New York Heart Association (NYHA) Class III or IV chronic heart failure or unstable angina pectoris
- History of any other endocrine disease
- History of a non-skin malignancy within the previous 5 years
- Anemia defined as hemoglobin less than 12 g/dL
- Renal insufficiency as defined by creatinine ³ 1.3 mg/dl
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition
- Uncontrolled hypertension (Systolic \>160 mm Hg and/or Diastolic \>100 mmHg on two consecutive measurements
- Use of warfarin, or any known coagulopathy and /or elevated Prothrombin time/Partial Thromboplastin Time (PT/PTT) \>1.5 x upper limit of normal (ULN)
- Self-reported history of Human immunodeficiency virus (HIV) positive
- Previous organ transplantation
- Clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests such as Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2x ULN, or self-reported history of positive for Hepatitis B or Hepatitis C
- Any major surgical procedure that occurred within the previous 3 months of the screening visit
- History of illicit drug abuse (\< 1 year)
- Regular use of alcoholic beverages (\> 2 drinks/day)
- Body mass index (BMI) \> 35 kg/m2 or \< 18.5 kg/m2
- Administration of an investigational drug within 6 weeks prior to the screening visit
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study will be excluded.
- Use of daily lipid-altering therapy prior to the initiation of study medication is exclusionary under the following circumstances (washout of non-statins is permitted):
- Statins within 4 weeks
- Niacin \> 250 mg/ day within 6 weeks: Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, or supplemental niacin
- Fibrates within 12 weeks: fenofibrate (Antara, Lofibra, Tricor, Triglide), gemfibrozil (Lopid), or clofibrate
- Enterically active lipid-altering drugs within 4 weeks: colestipol (Colestid), cholestyramine (Questran), colesevelam (Welchol), ezetimibe (Zetia, Vytorin), orlistat (Xenical, Alli)
- Red yeast rice
- Fish oil \> 2 g/day within 4 weeks: Lovaza (née Omacor), numerous supplements
- Altered dose of a selective estrogen receptor modulator (SERM) within 4 weeks
- History of severe intolerance of niacin
- Men who plan to conceive a child within 3 months of the conclusion of the study.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01250990
Start Date
November 1 2010
End Date
May 1 2011
Last Update
July 28 2016
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104