N/A N=40 Randomized Double-blind Treatment

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

Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00413400 ↗

Enrolled (actual)

Serious AEs

10.0%

Results posted

Dec 2010

Primary outcome: Primary: C-reactive Protein (CRP) — 0.61; 0.68 Log10 mg/L — p=0.20

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Etanercept (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY C-reactive Protein (CRP)	0.61; 0.68	0.20
PRIMARY Interleukin-6 (IL-6)	8.2; 11.3	0.92
PRIMARY Adiponectin	0.30; 0.40	0.02 sig
SECONDARY Glucose Tolerance	95; 91	0.02 sig
SECONDARY Endothelial Function	1.8; 2.0	0.46
SECONDARY White Blood Cell (WBC) Count	-0.17; -0.04	0.78
SECONDARY Cardiac Echo Ejection Fraction (EF)	1.1; -1.1	0.11
SECONDARY Body Composition	206; 186	0.59
SECONDARY Tumor Necrosis Factor (TNF) Receptor	2573; 4518	<0.0001 sig
SECONDARY Other Adipocytokines	6.7; 8.6	0.08
SECONDARY Lipid Levels	196; 201	0.55
SECONDARY Adipocyte Messenger Ribonucleic Acid (mRNA) Levels of Adipocytokines Including Tumor Necrosis Factor (TNF) -Alpha	2.3; 1.1	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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) = 140/90 or on medication

Exclusion Criteria

Age 60 years
Body mass index (BMI) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00413400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.