NCT00765284CompletedNot Applicable
Effect of Niaspan on Parameters of Reverse Cholesterol Transport and HDL-C Subclasses in Male Subjects With Low HDL-C Levels
KineMed1 site in 1 country15 target enrollmentStarted: December 2007Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects meeting the following criteria at the Screening Visit will be eligible to participate:
- •Provide written informed consent
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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.(8 weeks)
Investigators
Study Sites (1)
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