Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Intervention: Pioglitazone; Placebo; Niacin ER; Aspirin
Intervention description: Pioglitazone, initially 30 mg, then titrated to 45 mg/day; Pioglitazone placebo; Niacin ER 2.0 g/day; asprin 325 mg/day
Intervention MeSH terms: Aspirin; Niacin; Pioglitazone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Pioglitazone and placebo were overencapsulated
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HDL cholesterol; Metabolic syndrome

Summary:

      We will test our primary hypothesis that combining niacin extended release (niacin-ER), at a
      daily dosage of up to 2.0 g with pioglitazone, at a daily dosage of 45 mg will result in a
      12% greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in
      non-diabetic patients with the metabolic syndrome (see Table 1).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18 and 75

          2. HDL-C ≤ 40 mg/dL for Men and HDL-C < 50 mg/dl for Women*

          3. At least two of the following criteria (a, b, c, or d) listed below:

               1. Abdominal obesity (waist circumference: men 40 inches and women 35 inches)**

               2. Blood pressure > 130/>85 mmHg in untreated patients OR use of any
                  antihypertensive agent.

               3. Fasting glucose > 100 mg/dL but < 126 mg/dL

               4. Fasting triglycerides > 150 mg/dL

        Exclusion Criteria:

          1. Diabetes or use of anti-hyperglycemic medication in the last 3 months (subjects with a
             fasting blood glucose of > 110 mg/dL will have an oral glucose tolerance test (OGTT)
             to rule out diabetes mellitus).

          2. Subjects on statin therapy may be enrolled, but only if they have been on a stable
             dose for at least 3 months, and are not expected to require titration of statin
             therapy during the course of the study.

          3. Uncontrolled hypertension (defined as systolic bp > 180, diastolic BP > 100).

          4. Triglycerides > 400 mg/dL

          5. LDL-cholesterol level > 190 mg/dl

          6. History of chronic renal insufficiency (serum creatinine >2.0 mg/dl).

          7. History of liver disease or abnormal liver function tests (LFTs) (>2x upper limit
             normal)

          8. Hemoglobin < 10 mg/dL

          9. History of congestive heart failure (NYHA Class III or IV)

         10. Women who are pregnant or lactating

         11. History of a non-skin malignancy within the previous 5 years

         12. Any major active rheumatologic, pulmonary, or dermatologic disease or other chronic
             inflammatory condition

         13. Surgery in the last 90 days

         14. History of HIV positive

         15. Active alcohol or drug abuse

         16. Active peptic ulcer disease

         17. Gout attack within the past 6 months

         18. Participation in an investigational drug study within 6 weeks

         19. Serious or unstable medical or psychological conditions that, in the opinion of the
             investigator, would compromise the subject's safety or successful study participation

         20. Subjects on warfarin may be enrolled, but they will be excluded from the optional
             adipose biopsy.