Study of TNF-Antagonism in Metabolic Syndrome

Completed · Not applicable · Has a placebo group

Conditions studied: Metabolic Syndrome

In brief

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

Key facts

Study ID

NCT00409318

Run by

Massachusetts General Hospital

People needed

56

Starts

2004-04-01

Expected to finish

2005-05-01

Last updated by the study team

2008-05-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria based on a modified WHO definition of metabolic syndrome
• 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:
• Abdominal obesity defined by waist hip ratio > 0.90 for men and > 0.85 for women or BMI > 30 kg/m2
• 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
• Hypertension defined as blood pressure >= 140/90 or on medication

You may not qualify if…

• Positive PPD (³ 5mm induration) on screening
• Current Infection
• Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 3 months
• Reception of live vaccine within 1 week of recruitment
• History of blood dyscrasia including any kind of anemia, thrombocytopenia, pancytopenia. Women with a reversible cause of anemia that has resolved will be eligible.
• History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
• History of organ transplantation
• History of CNS demyelinating disorder or any first degree relative with multiple sclerosis
• History of CHF classes I-IV
• Current use of insulin, any oral anti-hyperglycemic agents, pentoxyfylline, beta-agonists
• Current use of fibrate or niacin
• Initiation of statin therapy within prior 6 weeks or expecting a change in statin dose over the upcoming 3 months
• Hemoglobin < 11 g/dl
• Positive pregnancy test
• Women of child-bearing potential not currently using non-hormonal birth control methods including barrier methods (IUD, condoms, diaphragms) or abstinence
• Patients with known autoimmune or inflammatory conditions (excluding patients with stable, treated hypothyroidism)

Where it is running

• MGH — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.