HDL CholesterolNCT00765284
Effect of Niaspan on Cholesterol in Men
An observational study of HDL Cholesterol, run by KineMed at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HDL Cholesterol
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Diabetes and Glandular Research Associates
San Antonio, Texas, 78229
About this study
Official title: Effect of Niaspan on Parameters of Reverse Cholesterol Transport and HDL-C Subclasses in Male Subjects With Low HDL-C Levels
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.
Read the 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.
- Conditions
- HDL Cholesterol
- Keywords
- HDL, RCT, Cholesterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HDL CholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KineMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Turner, PhD, Study director, KineMed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765284
- Sponsor's protocol ID
- KM-12
- Status last verified
- Jun 2011
- First submitted
- 30 Sep 2008
- Last updated
- 30 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Niaspan on Parameters of Reverse Cholesterol Transport and HDL-C Subclasses in Male Subjects With Low HDL-C Levels
- ClinicalTrials.gov ID
- NCT00765284
- Acronym / sponsor ID
- KM-12
- Conditions
- HDL Cholesterol
- Keywords
- HDL, RCT, Cholesterol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- KineMedIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Time frame: 8 weeks
1 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.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Turner, PhD study director
KineMed, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HDL Cholesterol, run by KineMed at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2011.