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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00111956
First Posted: May 27, 2005
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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 Phase
Metabolic Syndrome X Drug: Etanercept Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome

Resource links provided by NLM:


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

Primary Outcome Measures:
  • C-reactive protein (CRP), mg/L [ Time Frame: 25 days ]

Secondary Outcome Measures:
  • Adiponectin, ug/mL [ Time Frame: 25 days ]
  • Interleukin 6, ng/L [ Time Frame: 25 days ]
  • Fibrinogen, mg/dL [ Time Frame: 25 days ]
  • Insulin sensitivity [ Time Frame: 25 days ]

Enrollment: 56
Actual Study Start Date: April 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Etanercept Drug: Etanercept
Placebo Comparator: Placebo Drug: Placebo

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111956


Locations
United States, Massachusetts
Mass General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Massachusetts General Hospital
Investigators
Principal Investigator: Steven K Grinspoon, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00111956     History of Changes
Other Study ID Numbers: TNF-alpha (completed)
F32DK068902 ( U.S. NIH Grant/Contract )
First Submitted: May 26, 2005
First Posted: May 27, 2005
Last Update Posted: October 6, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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
Necrosis
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors