Effects of Niacin On Fatty Acid Trapping

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Arizona Pharmaceuticals Inc.; National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

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