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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00111956
First received: May 26, 2005
Last updated: January 12, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Metabolic Syndrome X
Drug: Etanercept

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • CRP
  • adiponectin

Secondary Outcome Measures:
  • Insulin sensitivity
  • safety

Estimated Enrollment: 56
Study Start Date: April 2004
Study Completion Date: May 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00111956

Locations
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00111956     History of Changes
Other Study ID Numbers: TNF-alpha (completed)
Study First Received: May 26, 2005
Last Updated: January 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
TNF
metabolic syndrome
inflammation
CRP
adiponectin

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014