Study of TNF-Antagonism in Metabolic Syndrome

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates whether blockade of TNF will result in reduced inflammatory indices in patients with the metabolic syndrome

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: Amgen
• Treatments: Etanercept

Criteria

Inclusion Criteria:

Inclusion Criteria based on a modified WHO definition of metabolic syndrome

1. Hyperinsulinemia in the upper quartile of the non-diabetic population defined as >= 10 mU/mL (Framingham Data, oral communication,James Meigs, MD) or fasting glucose 110-126 mg/dL

Plus two of the following:

2. Abdominal obesity defined by waist hip ratio > 0.90 for men and > 0.85 for women or BMI > 30 kg/m2

3. Dyslipidemia including serum triglycerides ³ 150 mg/dl or serum HDL < 0.9 mmol/L for men (35 mg/dL) and < 1.0 mmol/L (39mg/dL) for women

4. Hypertension defined as blood pressure >= 140/90 or on medication

Exclusion Criteria:

1. Positive PPD (³ 5mm induration) on screening

2. Current Infection

3. Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 3 months

4. Reception of live vaccine within 1 week of recruitment

5. History of blood dyscrasia including any kind of anemia, thrombocytopenia, pancytopenia. Women with a reversible cause of anemia that has resolved will be eligible.

6. History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)

7. History of organ transplantation

8. History of CNS demyelinating disorder or any first degree relative with multiple sclerosis

9. History of CHF classes I-IV

10. Current use of insulin, any oral anti-hyperglycemic agents, pentoxyfylline, beta-agonists

11. Current use of fibrate or niacin

12. Initiation of statin therapy within prior 6 weeks or expecting a change in statin dose over the upcoming 3 months

13. Hemoglobin < 11 g/dl

14. Positive pregnancy test

15. Women of child-bearing potential not currently using non-hormonal birth control methods including barrier methods (IUD, condoms, diaphragms) or abstinence

16. Patients with known autoimmune or inflammatory conditions (excluding patients with stable, treated hypothyroidism)