Effects of Niacin On Fatty Acid Trapping

Completed · Phase 1 · Has a placebo group

Conditions studied: Dyslipidemia

In brief

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.

Key facts

Study ID

NCT01984073

Run by

University of Pennsylvania

People needed

26

Starts

2012-12-01

Expected to finish

2019-12-01

Last updated by the study team

2020-07-09

Who can join

Age: 22 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Presbyterian Hospital — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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