Effect of Niaspan on Cholesterol in Men

NCT00765284 | Completed

• 1 other identifier: KM-12
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

HDL Cholesterol

Keywords

HDL; RCT; Cholesterol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KineMed: lead

Study Sites (1)

Diabetes and Glandular Research Associates

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool, urine, and blood samples will be taken and analyzed as part of the study.

Study Officials

• Scott Turner, PhD

  KineMed, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 30, 2011

Record last verified: 2011-06

Locations

US (1)