NCT00111956

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2005

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

May 26, 2005

Last Update Submit

October 4, 2017

Conditions

Metabolic Syndrome X

Keywords

TNFmetabolic syndromeinflammationCRPadiponectin

Outcome Measures

Primary Outcomes (1)

  • C-reactive protein (CRP), mg/L

    25 days

Secondary Outcomes (4)

  • Adiponectin, ug/mL

    25 days

  • Interleukin 6, ng/L

    25 days

  • Fibrinogen, mg/dL

    25 days

  • Insulin sensitivity

    25 days

Study Arms (2)

Etanercept

EXPERIMENTAL
Drug: Etanercept

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

EtanerceptDRUG
Etanercept
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Bernstein 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: 16636217RESULT

MeSH Terms

Conditions

Metabolic SyndromeInflammation

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Steven K Grinspoon, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2005

First Posted

May 27, 2005

Study Start

April 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

October 6, 2017

Record last verified: 2017-10

Locations

US(1)