NCT00409318

Brief Summary

This study investigates whether blockade of TNF will result in reduced inflammatory indices in patients with the 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 not_applicable

Timeline
Completed

Started Apr 2004

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
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

Enrollment Period

1.1 years

First QC Date

December 7, 2006

Last Update Submit

May 23, 2008

Conditions

Metabolic Syndrome

Keywords

InflammationVisceral adiposityTNFCRPAdiponectinInsulin resistancemetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • CRP

    4 weeks

Secondary Outcomes (13)

  • Insulin resistance

    4 weeks

  • Muscle adiposity

    4 weeks

  • High molecular weight adiponectin

    4 weeks

  • resistin

    4 weeks

  • leptin

    4 weeks

  • +8 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Etanercept

Drug: Etanercept

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

EtanerceptDRUG

50 mg SC q week

Also known as: Enbrel
1
PlaceboDRUG

SC q week

2

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 BMI \> 30 kg/m2
  • Dyslipidemia including serum triglycerides ³ 150 mg/dl or serum HDL \< 0.9 mmol/L for men (35 mg/dL) and \< 1.0 mmol/L (39mg/dL) for women
  • Hypertension defined as blood pressure \>= 140/90 or on medication

You may not qualify if:

  • Positive PPD (³ 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 CNS demyelinating disorder or any first degree relative with multiple sclerosis
  • History of 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 (IUD, condoms, diaphragms) or abstinence
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • 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

  • Zanni MV, Stanley TL, Makimura H, Chen CY, Grinspoon SK. Effects of TNF-alpha antagonism on E-selectin in obese subjects with metabolic dysregulation. Clin Endocrinol (Oxf). 2010 Jul;73(1):48-54. doi: 10.1111/j.1365-2265.2009.03741.x.

    PMID: 19878508DERIVED

MeSH Terms

Conditions

Metabolic SyndromeInflammationInsulin Resistance

Interventions

Etanercept

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose 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

    MGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

April 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

US(1)