Status:
COMPLETED
Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
Massachusetts General Hospital
Conditions:
Metabolic Syndrome X
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief Summary
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 wo...
Detailed Description
Screening visit 1: Fifty six patients will be randomized to receive etanercept or identical placebo. During the screening visit, after informed consent is obtained, subjects will undergo a medical hi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00111956
Start Date
April 1 2004
End Date
May 1 2005
Last Update
October 6 2017
Active Locations (1)
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1
Mass General Hospital
Boston, Massachusetts, United States, 02114