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

NCT00413400 | Completed Results DMC

• 1 other identifier: 2006-P-001060
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metabolic Syndrome

Keywords

Inflammation; Visceral adiposity; TNF; Adiponectin; glucose tolerance; endothelial function; metabolic syndrome

Outcome Measures

Primary Outcomes (3)

• 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

  6 months

• Interleukin-6 (IL-6)

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

  6 months

• Adiponectin

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

  6 months

Secondary Outcomes (9)

• Glucose Tolerance

  6 months

• Endothelial Function

  6 months

• White Blood Cell (WBC) Count

  Baseline to 6 months

• Cardiac Echo Ejection Fraction (EF)

  Baseline to 6 months

• Body Composition

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Etanercept

ACTIVE COMPARATOR

Drug: Etanercept

Interventions

Etanercept DRUG

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

Also known as: Enbrel

Etanercept

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Amgen: collaborator

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Inflammation

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Steven K. Grinspoon
• Organization: Massachusetts General Hospital

sgrinspoon@partners.org

617-724-9109

Study Officials

• Steven K Grinspoon

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 19, 2006
• Study Start: December 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: December 2, 2010
• Results First Posted: December 2, 2010

Record last verified: 2010-11

Locations

US (1)