HDL Cholesterol
Conditions
Keywords
HDL, RCT, Cholesterol
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.
Interventions
None listed
Sponsors
KineMed
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed