Effects of Niacin On Fatty Acid Trapping

NCT01984073 | Completed Phase 1

• 2 other identifiers: NOFATK23HL091130
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dyslipidemia

Keywords

Atherogenic dyslipidemia phenotype

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

ER Niacin Oral Fat Challenge

ACTIVE COMPARATOR

ER Niacin (Niaspan) 2000mg one hour prior to Oral Fat Challenge using fresh cream at a dose of 50 g fat per square meter of body surface area. This is followed by frequent plasma and urine collections for next 12 hours to assess markers of fat metabolism and inflammation.

Drug: ER Niacin Oral Fat Challenge

IR Niacin Oral Fat Challenge

ACTIVE COMPARATOR

Immediate-Release Niacin (Nialor) 500 mg one hour prior to Oral Fat Challenge and again 1, 3 and 5 hours after the oral fat load for a total dose of 2 grams.Subjects will undergo plasma and urine collections for 12 hours to assess markers of fat metabolism and inflammation.

Drug: IR Niacin Oral Fat Challenge

Placebo Oral Fat Challenge

PLACEBO COMPARATOR

Placebo one hour before and 1,3, and 5 hours after oral fat load using heavy cream at 50 grams of fat per square meter of body surface area. Plasma and urine collections for 12 hours

Other: Placebo Oral Fat Challenge

Interventions

ER Niacin Oral Fat Challenge DRUG

Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.

Also known as: Niaspan

ER Niacin Oral Fat Challenge

IR Niacin Oral Fat Challenge DRUG

Nialor(R) 500mg or Placebo at hour 0, 2, 4, and 6. Oral fat challenge at hour 1 (one hour after first dose of immediate-release niacin)

Also known as: Nialor

IR Niacin Oral Fat Challenge

Placebo Oral Fat Challenge OTHER

Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6

Placebo Oral Fat Challenge

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Arizona Pharmaceuticals Inc.: collaborator

Study Sites (2)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Presbyterian Hospital

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

Niacin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Richard L Dunbar, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 14, 2013
• Study Start: December 1, 2012
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)