Effect of Niaspan on Cholesterol in Men

HDL Cholesterol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765284
• Other study ID #: KM-12
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: June 29, 2011
• Start date: December 2007
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: KineMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• HDL Cholesterol

Locations

Country	Name	City	State
United States	Diabetes and Glandular Research Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
KineMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No