Metabolic SyndromeNCT00409318
Study of TNF-Antagonism in Metabolic Syndrome
A study testing Etanercept in people with Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study investigates whether blockade of TNF will result in reduced inflammatory indices in patients with the metabolic syndrome Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Etanercept
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inclusion Criteria based on a modified WHO definition of metabolic syndrome
- 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
Who cannot join
- 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)
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- 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
- Patients with known autoimmune or inflammatory conditions (excluding patients with stable, treated hypothyroidism)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of TNF-Alpha Antagonism in Patients With the Metabolic Syndrome (I)
This study investigates whether blockade of TNF will result in reduced inflammatory indices 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). 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
- Metabolic Syndrome
- Being tested
- Etanercept, Placebo
- Keywords
- Inflammation, Visceral adiposity, TNF, CRP, Adiponectin, Insulin resistance, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Inflammation, Insulin Resistance
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 SC q week
PlaceboDrug
SC q week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Etanercept Receives: Drug: Etanercept |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP
Measured: 4 weeks
Secondary outcomes (13)
Insulin resistance
Measured: 4 weeks
Muscle adiposity
Measured: 4 weeks
High molecular weight adiponectin
Measured: 4 weeks
resistin
Measured: 4 weeks
leptin
Measured: 4 weeks
TNF-R1
Measured: 4 weeks
TNF-R2
Measured: 4 weeks
weight
Measured: 4 weeks
WBC
Measured: 4 weeks
Lipids
Measured: 4 weeks
IL-6
Measured: 4 weeks
Fibrinogen
Measured: 4 weeks
adiponectin
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startApr 2004
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Investigators
- Steven K Grinspoon, Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409318
- Sponsor's protocol ID
- 2003-P-001699
- Status last verified
- May 2008
- First submitted
- 7 Dec 2006
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16636217Zanni 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.
PubMed 19878508
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TNF-Alpha Antagonism in Patients With the Metabolic Syndrome (I)
- ClinicalTrials.gov ID
- NCT00409318
- Acronym / sponsor ID
- 2003-P-001699
- Conditions
- Metabolic Syndrome
- Keywords
- Inflammation, Visceral adiposity, TNF, CRP, Adiponectin, Insulin resistance, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- Apr 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 8 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates whether blockade of TNF will result in reduced inflammatory indices in patients with the metabolic syndrome
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). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EtanerceptEtanercept |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Inclusion Criteria based on a modified WHO definition of metabolic syndrome
- 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
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: Enbrel50 mg SC q week | Drug | 1 |
| PlaceboSC q week | Drug | 2 |
Primary outcome
CRP
Time frame: 4 weeks
13 secondary outcomes
Insulin resistance
Time frame: 4 weeks
Muscle adiposity
Time frame: 4 weeks
High molecular weight adiponectin
Time frame: 4 weeks
resistin
Time frame: 4 weeks
leptin
Time frame: 4 weeks
TNF-R1
Time frame: 4 weeks
TNF-R2
Time frame: 4 weeks
weight
Time frame: 4 weeks
WBC
Time frame: 4 weeks
Lipids
Time frame: 4 weeks
IL-6
Time frame: 4 weeks
Fibrinogen
Time frame: 4 weeks
adiponectin
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Results publication: PubMed 16636217Bernstein 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.
- Derived from this study: PubMed 19878508Zanni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven K Grinspoon principal investigator
MGH
1 site in 1 country: see every site and its status.
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 6 inclusion and 16 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 28 May 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CRP (time frame: 4 weeks). 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 NCT00409318, which also lists 2 linked publications.
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 28 May 2008.