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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014