Status:
COMPLETED
Niacin, N-3 Fatty Acids and Insulin Resistance
Lead Sponsor:
University of South Dakota
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Metabolic Syndrome
Hypertriglyceridemia
Eligibility:
All Genders
40-69 years
Phase:
PHASE4
Brief Summary
This research study is being conducted to test the effects of two drugs on blood lipids (cholesterol and triglycerides) and blood sugar (glucose) levels in patients with diabetes or "pre-diabetes" (bo...
Detailed Description
The insulin resistance syndrome (IRS) afflicts approximately 25% of the US adult population. Its principal components include some or all of the following: central obesity, elevated triglyceride level...
Eligibility Criteria
Inclusion
- 40 and 69 years of age Male or female (without hormonal cycling as described below) BMI \> 25 Fasting serum triglycerides \> 150 mg/dL Ratio of TG/HDL-C \> 3.5
Exclusion
- BMIs \> 40 kg/m2 TG \> 750 mg/dL HDL-C \< 10 mg/dL Presence of other secondary causes of dyslipidemia or hyperglycemia such as hepatic, renal, thyroid or other endocrine diseases History of hypersensitivity to niacin or fish oils History of gout, hepatitis, peptic ulcer or cardiovascular disease Presence of diabetes mellitus, whether controlled by diet or drugs. (We will eliminate subjects with undiagnosed diabetes by screening for fasting glucose \> 126 mg/dL) Use of any dietary supplements providing more than 50 mg of niacin or 100 mg of n-3 FA Use of any herbal preparations or weight-loss products Taking any lipid-lowering drugs for at least four weeks prior to screening for the study Medically-required treatment with nitrates, calcium channel blockers, or adrenergic blocking agents (per the Niaspan package insert) Hemoglobin \< 12 g/dL (owing to the significant amount of blood being drawn) LDL-C \> 145 mg/dL. (This restriction will prevent the randomization of any subject whose LDL-C levels, if assigned to an n-3 FA group, might rise by 10% and thus exceed 160 mg/dL) Known substance abuse Participation in a clinical drug trial anytime during the 30 days prior to screening Anyone whom the investigators judge to be a poor candidate
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00286234
Start Date
October 1 2007
End Date
December 1 2008
Last Update
October 26 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanford Clinic Clinical Research Services
Sioux Falls, South Dakota, United States, 57105