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Effect of Niaspan on Cholesterol in Men

Information source: KineMed
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HDL Cholesterol

Phase: N/A

Status: Completed

Sponsored by: KineMed

Official(s) and/or principal investigator(s):
Scott Turner, PhD, Study Director, Affiliation: KineMed, Inc.

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.

Clinical Details

Official title: Effect of Niaspan on Parameters of Reverse Cholesterol Transport and HDL-C Subclasses in Male Subjects With Low HDL-C Levels

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: 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.

Secondary outcome: 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.

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.

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

Locations and Contacts

Diabetes and Glandular Research Associates, San Antonio, Texas 78229, United States
Additional Information

Starting date: December 2007
Last updated: June 29, 2011

Page last updated: August 23, 2015

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