Effect of Niacin on Transport of HDL and Relationship to Atherogenic Lipoproteins and Lipolysis

NCT01250990 | Completed Results

• 2 other identifiers: 811956K23HL091130
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dyslipidemias

Keywords

Niacin; HDL; Reverse cholesterol transport

Outcome Measures

Primary Outcomes (1)

• Rate of Appearance of 3H Cholesterol in the Total HDL Fraction Before and After 12 Weeks of Treatment With Niacin

  Subjects were injected with a bolus of 3-H cholesterol mixed with human serum albumin as an intravenous bolus. This injected labelled cholesterol is taken up by macrophages. The rate of appearance of labelled cholesterol in plasma HDL- cholesterol is a measure of reverse cholesterol transport. We assessed HDL cholesterol enrichment as percent of injected tritiated tracer appearing in plasma total HDL cholesterol between 60 and 240 minutes post-injection expressed as percent 3-H cholesterol/mol HDL cholesterol/hour. The tracer study was performed at baseline and after 12 weeks of niacin or placebo.

  Baseline and 12 weeks

Study Arms (2)

Niacin

ACTIVE COMPARATOR

Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Drug: Niacin

Placebo

PLACEBO COMPARATOR

Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.

Other: Placebo

Interventions

Niacin DRUG

Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.

Also known as: Niacor and Niaspan

Niacin

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18 and 75 inclusive
• HDL cholesterol \>= 25 mg/dL in all subjects, and \<= 60 mg/dL in men and \<= 70 mg/dL in women
• Subjects must be in good overall health.
• Subjects must be able to comprehend and willing to provide a signed Institutional Regulatory Board (IRB) approved Informed Consent Form.
• Subjects must be willing to comply with all study-related procedures.
• Subjects must weigh at least 140 pounds to participate in the HDL kinetics Substudy.

You may not qualify if:

• Clinically-manifest cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease
• History of diabetes mellitus or fasting glucose \> 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 (\< 1 year)

Sponsors & Collaborators

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

Study Sites (1)

University of Pennsylvania

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

Results Point of Contact

• Title: Richard L Dunbar
• Organization: University of Pennsylvania

richard.dunbar@uphs.upenn.edu

215-662-9024

Study Officials

• Richard Dunbar, MD MSTR

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 1, 2010
• Study Start: November 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 28, 2016
• Results First Posted: June 24, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)