Dyslipidemia Clinical Trial
— NOFATOfficial title:
Effect of Niacin On Fatty Acid Trapping
Verified date | July 2020 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more efficiently. This is important because people with dyslipidemia have a problem with how they process fat, which raise the risk of heart disease.
Status | Completed |
Enrollment | 26 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Meet protocol defined criteria for atherogenic dyslipidemia phenotype - Men and non-pregnant, non-lactating women between the ages of 22 and 75 - Fasting triglycerides <500 mg/dL - Ability to understand and agree to informed consent - Willingness to comply with study-related procedures Exclusion Criteria: - Dysbetalipoproteinemia - History of extreme triglyceridemia (TG >500 mg/dL) or pancreatitis from triglyceridemia, regardless of whether it is currently controlled - LDL >190 mg/dL - History of chronic renal insufficiency (serum creatinine >2.0 mg/dL) - History of non-skin malignancy within the previous 5 years - Subject reported history of HIV - Uncontrolled thyroid disease - Hypoalbuminemia (serum albumin >2.5 mg/dL) - Exposure to an investigational drug within 6 weeks prior to the screening visit - Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition - Major surgery within the previous 6 weeks - Subjects who have undergone any organ transplant - History of drug abuse within the past 3 years, or regular alcohol use >14 drinks per week - Women who are breast-feeding - Women who are pregnant by urine pregnancy test at each 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 - Change in statin dose within 6 weeks of the first experimental visit - Use of the following non-statin lipid-altering therapy within 6 weeks of the first experimental visit: Niacin > 100 mg/day (Niacor, Slo-Niacin, Niaspan, Advicor, or supplemental niacin), Fibrates [gemfibrozil (Lopid), fenofibrate (Antara, Lofibra, Tricor, Triglide)], Enterically active drugs [colestipol (Colestid), cholestyramine (Questran), colesevelam (Welchol), ezetimibe (Zetia, Vytorin)], Red yeast rice, Fish oil (Omacor, numerous supplements) - Use of medications indicated for the treatment of diabetes within 6 weeks of the screening visit - Known intolerance or contraindication to niacin (e.g., moderate to severe gout, severe peptic ulcer disease) - Medical condition that would prohibit fasting (e.g., diagnosis of insulinoma or postabsorptive hypoglycemia) - Significant disinclination to dairy products (e.g., lactose intolerance, inviolable dietary restrictions) - History of anaphylactic reaction - For indocyanine green substudy: iodine allergy or shellfish allergy (n.b. a subject with an allergy can participate in the overall experiment, but will forego the indocyanine green tracer study) - Donation of blood 8 weeks and/or treatment with medications for psychiatric disorders - Hemoglobin <10 g/dL |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Presbyterian Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Arizona Pharmaceuticals Inc., National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma Triglycerides | Plasma Triglycerides (TGs) after oral fat challenge will be measured to assess post-prandial lipidemia after niacin and placebo. Parameters of interest are the area under the curve (AUC), time to peak (t-max), and peak concentration (c-max). The relevant units will be mg.h/dl for plasma triglyceride AUC, minutes for time to peak plasma TG and mg/dl for c-max. | Baseline to 12 hour post dose |
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