Clinical trial · Interventional
Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome
NCT00111956CI-TRIAL-00029801completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metabolic Syndrome X | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etanercept | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Etanercept
- interventionNames
- Drug: Etanercept
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- C-reactive protein (CRP), mg/L
- timeFrame
- 25 days
Secondary outcomes (4)
- measure
- Adiponectin, ug/mL
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (1)
- RESULTBernstein LE, Berry J, Kim S, Canavan B, Grinspoon SK. Effects of etanercept in patients with the metabolic syndrome. Arch Intern Med. 2006 Apr 24;166(8):902-8. doi: 10.1001/archinte.166.8.902. PMID 16636217