MedDataX Logo

Study of TNF-Antagonism in Metabolic Syndrome

NCT ID: NCT00409318

Last Updated: 2008-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome, insulin resistance, and coronary artery disease (CAD). TNF-alpha is an inflammatory cytokine that is increased in a spectrum of inflammatory diseases as well as in insulin resistance. TNF-alpha antagonists are clinically effective in the inflammation of arthritides, but have not been examined in the metabolic syndrome population. Moreover, data suggests that adiponectin, a recently discovered adipocytokine that may protect against the development of insulin resistance and atherosclerosis, may be downregulated by TNF-alpha. We propose a study in which we administer etanercept, a TNF-alpha receptor fusion protein, to subjects with metabolic syndrome to examine its effect on inflammatory markers,CRP, adiponectin and insulin resistance. This would be the first study to investigate the anti-inflammatory properties and insulin sensitizing potential of TNF-alpha blockade on the growing population with metabolic syndrome.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Inflammation Visceral adiposity TNF CRP Adiponectin Insulin resistance metabolic syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Etanercept

Group Type ACTIVE_COMPARATOR

Etanercept

Intervention Type DRUG

50 mg SC q week

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC q week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Etanercept

50 mg SC q week

Intervention Type DRUG

Placebo

SC q week

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enbrel

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. 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:
2. Abdominal obesity defined by waist hip ratio \> 0.90 for men and \> 0.85 for women or BMI \> 30 kg/m2
3. 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
4. Hypertension defined as blood pressure \>= 140/90 or on medication

Exclusion Criteria

1. Positive PPD (³ 5mm induration) on screening
2. Current Infection
3. Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 3 months
4. Reception of live vaccine within 1 week of recruitment
5. History of blood dyscrasia including any kind of anemia, thrombocytopenia, pancytopenia. Women with a reversible cause of anemia that has resolved will be eligible.
6. History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
7. History of organ transplantation
8. History of CNS demyelinating disorder or any first degree relative with multiple sclerosis
9. History of CHF classes I-IV
10. Current use of insulin, any oral anti-hyperglycemic agents, pentoxyfylline, beta-agonists
11. Current use of fibrate or niacin
12. Initiation of statin therapy within prior 6 weeks or expecting a change in statin dose over the upcoming 3 months
13. Hemoglobin \< 11 g/dl
14. Positive pregnancy test
15. Women of child-bearing potential not currently using non-hormonal birth control methods including barrier methods (IUD, condoms, diaphragms) or abstinence
16. Patients with known autoimmune or inflammatory conditions (excluding patients with stable, treated hypothyroidism)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Amgen

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

MGH

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven K Grinspoon

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

MGH

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 16636217 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19878508 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2003-P-001699

Identifier Type: -

Identifier Source: org_study_id