Status:
COMPLETED
Effect of Niaspan on Cholesterol in Men
Lead Sponsor:
KineMed
Conditions:
HDL Cholesterol
Eligibility:
MALE
18-70 years
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 treat...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00765284
Start Date
December 1 2007
End Date
June 1 2011
Last Update
June 30 2011
Active Locations (1)
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1
Diabetes and Glandular Research Associates
San Antonio, Texas, United States, 78229