AzTrials
AzTrials

Metabolic SyndromeNCT00413400

Study of TNF-Antagonism in the Metabolic Syndrome (II)

A study testing Etanercept in people with Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will investigate whether etanercept will result in improved inflammatory indices, glucose tolerance and endothelial function in patients with the metabolic syndrome. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Metabolic Syndrome
What is being tested?
Etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Dec 2006to Sep 2009
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Hyperinsulinemia in the upper quartile of the non-diabetic population defined as >= 10 mU/mL (based on 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 and BMI > 30 kg/m2
  • Dyslipidemia including serum triglycerides >= 150 mg/dl or serum high density lipoprotein (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

Who cannot join

  • Age < 18 or > 60 years
  • Body mass index (BMI) < 30 kg/m2
  • Positive tuberculosis (purified protein derivative [PPD]) skin test (5mm induration or more) on screening
  • Mycobacterial disease treated less than 6 months.
  • Current or recurrent infection or any underlying condition that may predispose to infection or anyone who has been admitted to the hospital due to bacteremia, pneumonia or any other serious infection.
  • Therapy with glucocorticoid or immunosuppressant at time of recruitment or within past 3 months.
Show all 29Show fewer
  • Prior or concurrent cyclophosphamide therapy
  • Use of a live vaccine 90 days prior to, or during this study.
  • History of blood dyscrasia including any kind of anemia, thrombocytopenia, pancytopenia. Women with a reversible cause of anemia that has resolved will be eligible.
  • Hemoglobin < 11 g/dl
  • History of malignancy (except patients with surgically cured basal cell or squamous cell skin cancers who will be eligible)
  • History of organ transplantation
  • HIV-positive status determined by HIV test at screening or known history of any other immuno-suppressing disease.
  • Hepatitis B or hepatitis C infection detected at screening, lupus (SLE), history of multiple sclerosis, transverse myelitis, optic neuritis or epilepsy
  • Patients with known autoimmune or inflammatory conditions (excluding patients with stable, treated hypothyroidism)
  • Severe comorbidities (diabetes mellitus requiring insulin, congestive heart failure (CHF) (EF<50% at baseline will be exclusionary) of any severity, myocardial infarction (MI), cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 3 months of screening visit, unstable angina pectoris, oxygen-dependent severe pulmonary disease
  • Uncontrolled systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg
  • Fasting blood glucose > 126 mg/dL
  • Creatinine > 1.5
  • Current use of insulin, any oral anti-hyperglycemic agents (including insulin sensitizing agents). Initiation of insulin, oral hypoglycemics, or insulin sensitizing agents during the study will result in discontinuation from the study.
  • Initiation of statins, niacin, antihypertensive or fibrate therapy within 6 weeks of the study. Chronic use of fibrates, niacin, or antihypertensives for > 6 weeks prior to study initiation at a stable dose is not exclusionary, but chronic use of statins for > 6 months is exclusionary. Initiation of statins, fibrates, niacin or antihypertensive treatments during the study is not exclusionary but will be considered in the analysis (see Protection against risks).
  • Positive pregnancy test or lactating females
  • Women of child-bearing potential not currently using non-hormonal birth control methods including barrier methods (intrauterine device [IUD], condoms, diaphragms) or abstinence
  • Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit.
  • Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept
  • Concurrent sulfasalazine therapy
  • History of recent alcohol or substance abuse (< 1 year)
  • Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.
  • History of non-compliance with other therapies

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MGH

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Effects of Etanercept in Patients With the Metabolic Syndrome (II)

This study will investigate whether etanercept will result in improved inflammatory indices, glucose tolerance and endothelial function in patients with the metabolic syndrome.

Read the detailed description

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). Tumor Necrosis Factor (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, and have recently been shown by our group to decrease inflammatory cardiovascular risk markers in metabolic syndrome. 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. In addition, population based studies have shown that those with the highest levels of TNF-alpha have an increased relative risk of cardiovascular morbidity while rheumatoid arthritis patients treated with TNF-alpha blockade appear protected from cardiovascular disease. We will perform a 6-month study in which we will administer etanercept, a TNF-alpha receptor fusion protein, to subjects with metabolic syndrome to investigate its effect on surrogate markers of cardiovascular disease, including inflammatory markers, adiponectin and glucose tolerance and endothelial function. The results of the proposed study will have broad implications regarding the physiological role of TNF-alpha on the inflammatory cascade, cardiovascular indices and endothelial function.

Being tested
Etanercept, Placebo
Keywords
Inflammation, Visceral adiposity, TNF, Adiponectin, glucose tolerance, endothelial function, metabolic syndrome
Medical subject headings
Metabolic Syndrome, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EtanerceptDrug

    Also called Enbrel

    50 mg one syringe sc 2X per week for three months followed by 50 mg one syringe sc 1X per week for three months

  • PlaceboDrug

    50 mg one syringe sc 2x per week for three months followed by 50 mg one syringe sc 1X per week for three months

Study groups in NCT00413400
Study groupRoleWhat they receive
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
EtanerceptActive comparatorNot described
Receives: Drug: Etanercept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. C-reactive Protein (CRP)

    As a measure of C-reactive protein (CRP), which is an inflammatory marker, Log10 of the CRP at 6 months is reported

    Measured: 6 months

  2. Interleukin-6 (IL-6)

    6 month value of IL-6 (pg/mL)

    Measured: 6 months

  3. Adiponectin

    The ratio of circulating high molecular weight (HMW) adiponectin to total adiponectin ratio (HMW:total Adiponectin) at 6 months is reported.

    Measured: 6 months

Secondary outcomes (9)

  1. Glucose Tolerance

    Fasting glucose (mg/dL) at 6mo

    Measured: 6 months

  2. Endothelial Function

    Reactive Hyperemia Index (RHI) using peripheral artery tonometry (using Endo-PAT 2000). Peripheral artery tonometry measures blood flow in the tip of the index finger at baseline and in response to vaso-occlusion (inflated blood pressure cuff). The reactive hyperemia index is an index of vasodilation after occlusion compared to baseline. A higher value indicates better vasoreactivity. As this is a relatively new test, there are no thoroughly validated clinically utilized norms.

    Measured: 6 months

  3. White Blood Cell (WBC) Count

    Change in WBC during study (WBC at six months minus WBC at baseline)

    Measured: Baseline to 6 months

  4. Cardiac Echo Ejection Fraction (EF)

    change in EF (6mo - baseline). Please note that the value given is the absolute change in EF (which has units of percent), not the percent change in the variable.

    Measured: Baseline to 6 months

  5. Body Composition

    6 month visceral adipose tissue (cm^2) - cross-sectional area of the visceral adipose tissue at the level of the 4th lumbar vertebrae was measured using single-slice abdominal computed tomography (CT) scan

    Measured: 6 months

  6. Tumor Necrosis Factor (TNF) Receptor

    Circulating concentrations of Tumor necrosis factor receptor 2 (TNFR2) at 6 months

    Measured: 6 months

  7. Other Adipocytokines

    circulating resistin at 6 months

    Measured: 6 months

  8. Lipid Levels

    total cholesterol (mg/dL) at 6 months

    Measured: 6 months

  9. Adipocyte Messenger Ribonucleic Acid (mRNA) Levels of Adipocytokines Including Tumor Necrosis Factor (TNF) -Alpha

    fold-change in subcutaneous adipose tissue expression of TNF-alpha (mRNA) after 6 months

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413400
Sponsor's protocol ID
2006-P-001060
Status last verified
Nov 2010
First submitted
7 Dec 2006
Last updated
2 Dec 2010
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Etanercept in people with Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-reactive Protein (CRP) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00413400.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2010.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in