N/A
N=22
Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis
Dyslipidemias
Bottom Line
View on ClinicalTrials.gov: NCT01250990 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin — 3.24; 4.16; 2.61; 3.72 %/mol/h — p=0.8
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Niacin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin |
3.24; 4.16; 2.61; 3.72 | 0.8 |
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 plasma, lipoproteins, red blood cells (RBCs) and stool. The hypothesis is that niacin augments reverse cholesterol transport.
Eligibility Criteria
Inclusion Criteria
- Men and women between the ages of 18 and 75 inclusive
- HDL cholesterol >= 25 mg/dL in all subjects, and 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 ( 2 drinks/day)
- Body mass index (BMI) > 35 kg/m2 or 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.
Data sourced from ClinicalTrials.gov (NCT01250990). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.