Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Metabolic Syndrome X

In brief

Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.

Key facts

Study ID

NCT00111956

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

56

Starts

2004-04-01

Expected to finish

2005-05-01

Last updated by the study team

2017-10-06

Who can join

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

You may qualify if…

• 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 *body mass index (BMI) > 30 kg/m2
• Dyslipidemia including serum triglycerides ≥150 mg/dl or serum HDL < 0.9 mmol/L for men (35 mg/dL) and < 1.0 mmol/L (39 mg/dL) for women
• Hypertension defined as blood pressure ≥ 140/90 or on medication

You may not qualify if…

• Positive PPD (≥ 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 central nervous system (CNS) demyelinating disorder or any first degree relative with multiple sclerosis
• History of congestive heart failure (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 (intrauterine device (IUD), condoms, diaphragms) or abstinence
• Patients with known autoimmune or inflammatory conditions

Where it is running

• Mass General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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