Status:
COMPLETED
Study of TNF-Antagonism in Metabolic Syndrome
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Amgen
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study investigates whether blockade of TNF will result in reduced inflammatory indices in patients with the metabolic syndrome
Detailed Description
Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical inflammatory state i...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
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
NCT00409318
Start Date
April 1 2004
End Date
May 1 2005
Last Update
May 28 2008
Active Locations (1)
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1
MGH
Boston, Massachusetts, United States, 02114