Effect of Niaspan on Cholesterol in Men

This study has been completed.
Sponsor:
Information provided by:
KineMed
ClinicalTrials.gov Identifier:
NCT00765284
First received: September 30, 2008
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

To determine whether 8 weeks of Niaspan treatment increases cholesterol efflux in male subjects with low HDL-C cholesterol when compared to no treatment.

To determine whether 8 weeks of Niaspan treatment increases fecal cholesterol excretion when compared to no treatment.

To determine whether 8 weeks of Niaspan treatment increases the rate of global reverse cholesterol transport when compared to no treatment.


Condition
HDL Cholesterol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Niaspan on Parameters of Reverse Cholesterol Transport and HDL-C Subclasses in Male Subjects With Low HDL-C Levels

Resource links provided by NLM:


Further study details as provided by KineMed:

Primary Outcome Measures:
  • To determine whether 8 weeks of Niaspan treatment increases the following: cholesterol efflux, fecal cholesterol excretion, and the rate of global reverse cholesterol transport, in male subjects with low HDL-C cholesterol when compared to no treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the longitudinal effects of 8 weeks of Niaspan treatment on percent change in concentration of specific HDL-C sub-fractions when compared to no treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Stool, urine, and blood samples will be taken and analyzed as part of the study.


Estimated Enrollment: 15
Study Start Date: December 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treatment
Ten subjects will be low HDL-C male volunteers who will receive aspirin and Niaspan
Placebo
Five subjects will be low HDL-C male volunteers who will receive only aspirin.

Detailed Description:

This will be a single center, open-label, randomized, mechanism of action study consisting of 8 weeks of active treatment preceded by a screening phase from one to 8 weeks and a baseline measurement of parameters of reverse cholesterol transport for 10 days. The population for this trial is 15 non-diabetic men aged 18-70 years. Ten subjects will be low HDL-C male volunteers who will receive aspirin and Niaspan and five subjects will be low HDL-C male volunteers who will receive only aspirin.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Study will include a total of 15 subjects, non-diabetic men with low HDL-C, defined as <40 mg/dL. Subjects will be aged 18 to 70 years and have a BMI between 18.5-40 kg/m2.

Criteria

Inclusion Criteria:

Subjects meeting the following criteria at the Screening Visit will be eligible to participate:

  • Provide written informed consent
  • Male
  • Age 18 to 70 years
  • BMI 18.5-40 kg/m2
  • HDL-C values <40 mg/dL
  • Triglyceride value 150-500 mg/dL.
  • Good health based on medical history, physical examination and laboratory safety tests performed at the screening visit or prior to initial dose of study medication.
  • No clinically significant abnormality on ECG performed at the screening visit or prior to initial dose of study medication.
  • Non-smoker and no other use of nicotine containing products for at least 6 months and does not plan to begin smoking during the course of the study.
  • Dietary or nutritional remedies including plant sterol containing products (i.e. Benecol, SmartBalance, etc) of any sort for at least 2 weeks prior to and throughout the study.
  • Willing to avoid the use of lipid modifying medications (excluding statins) such as the fibrates, cholestyramine, fish oil, and ezetimibe within 8 weeks prior to and during the study.
  • Avoidance of extreme change of physical activity from screening through the follow-up period.

Exclusion Criteria:

Subjects are excluded from participation in the study if any of the following criteria apply:

  • History of intolerance to Niacin or Niaspan.
  • Treatment with Niacin or Niaspan in the past 3 months (Multivitamin use with non-pharmacologic doses of Niacin - less than 500mg per day - is allowed).
  • History of stroke, chronic seizures, or major neurological disorder.
  • Significant emotional problems or a history of clinically significant psychiatric disorder.
  • Bleeding diathesis or intolerance to aspirin.
  • Anemia as defined as a hematocrit < 25%.
  • History of gastritis, bleeding gastric or duodenal ulcers.
  • History Type 1 or Type 2 diabetes, or fasting plasma glucose >125 mg/dL at screening or 75 gm OGTT with 2 hour glucose >140mg/dL.
  • History of illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk through participation.
  • History of ileal bypass, gastric bypass, or other condition associated with malabsorption.
  • Abnormal thyroid function tests.
  • AST or ALT > 1.5x the upper limit of normal.
  • Active or recent gastrointestinal condition such as gastroenteritis, irritable bowel syndrome, chronic constipation, or diarrhea which may affect bowel movements.
  • History of plant sterol storage disease or a history of intolerance to plant sterols or plant sterol containing products.
  • History of neoplastic disease (i.e. leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment. Exceptions include adequately treated non-melanomatous skin carcinoma, and other malignancies that may have been treated successfully >10 years prior to the screening visit with no evidence of recurrence.
  • Excessive alcohol consumption defined as > three glasses of alcoholic beverages or distilled spirits per day. *** Must avoid excessive alcohol consumption throughout study.
  • Currently using psyllium or other fiber based laxatives, phytosterol margarines, and/or over the counter (OTC) treatments that are known to affect serum lipids and has NOT been treated with a stable regimen for > 6 weeks prior to screening (Visit 1) or the subject DOES NOT agree to continue this regimen for the duration of the clinical trial.
  • Regular user of illicit drugs or history of drug abuse (including alcohol) within the previous 2 years.
  • Use of anabolic agents.
  • Any condition or therapy which, in the opinion of the investigator, poses a risk to the subject
  • Use of any investigational drug within 30 days before screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765284

Locations
United States, Texas
Diabetes and Glandular Research Associates
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
KineMed
Investigators
Study Director: Scott Turner, PhD KineMed, Inc.
  More Information

No publications provided

Responsible Party: Drina Boban/ Clinical Studies Director, KineMed, Inc.
ClinicalTrials.gov Identifier: NCT00765284     History of Changes
Other Study ID Numbers: KM-12
Study First Received: September 30, 2008
Last Updated: June 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by KineMed:
HDL
RCT
Cholesterol

ClinicalTrials.gov processed this record on April 23, 2014