ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome

This study has been completed.

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00111956
  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

MedlinePlus related topics:   Metabolic Syndrome   

ChemIDplus related topics:   Etanercept    Tumor Necrosis Factors   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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  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

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


Study ID Numbers:   TNF-alpha
First Received:   May 26, 2005
Last Updated:   December 12, 2007
ClinicalTrials.gov Identifier:   NCT00111956
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  

Study placed in the following topic categories:
Hyperinsulinism
Necrosis
Metabolic Diseases
Metabolic Syndrome X
Syndrome X
Insulin Resistance
TNFR-Fc fusion protein
Metabolic disorder
Glucose Metabolism Disorders
Abdominal obesity metabolic syndrome
Inflammation

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Disease
Immunologic Factors
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Syndrome
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers