Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- C-reactive protein (CRP), mg/L
研究概览
简要总结
Metabolic syndrome is associated with increased inflammatory cytokines and reduced adiponectin, that may be mediated in part by TNF production from abdominal fat. We reasoned that an anti-TNF agent would reduce C-reactive protein (CRP) and increase adiponectin, improving the inflammatory milieu associated with metabolic syndrome.
详细描述
Screening visit 1:
Fifty six patients will be randomized to receive etanercept or identical placebo. During the screening visit, after informed consent is obtained, subjects will undergo a medical history and physical exam, which will include vital signs, weight, abdominal girth measurements and an evaluation for signs of underlying infection. A purified protein derivative (PPD) of 5 tuberculin units (TU) (0.1 milliliter of 5 TU/0.1 ml solution) will be intradermally placed to test for the presence of tuberculosis (TB). Fasting blood work will include a complete blood count (CBC), glucose, insulin, a cholesterol panel, and urine pregnancy test. Subjects will be shown what a subcutaneous injection entails using placebo. Patients will be selected based on their laboratory results, abdominal girth measurements and PPD negativity 48 hrs after placement.
Screening visit 2:
Subjects will return 48 hours after their first screening visit for evaluation of their PPD test. In the event of a positive PPD, subjects will be excluded from the study, and their primary care physicians will be notified of their test result.
Day 1 visit:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 *body mass index (BMI) > 30 kg/m2
- •Dyslipidemia including serum triglycerides ≥150 mg/dl or serum HDL < 0.9 mmol/L for men (35 mg/dL) and < 1.0 mmol/L (39 mg/dL) for women
- •Hypertension defined as blood pressure ≥ 140/90 or on medication
排除标准
- •Positive PPD (≥ 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)
- •History of organ transplantation
- •History of central nervous system (CNS) demyelinating disorder or any first degree relative with multiple sclerosis
- •History of congestive heart failure (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 (intrauterine device (IUD), condoms, diaphragms) or abstinence
- •Patients with known autoimmune or inflammatory conditions
研究组 & 干预措施
Etanercept
干预措施: Etanercept (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
C-reactive protein (CRP), mg/L
时间窗: 25 days
次要结局
- Adiponectin, ug/mL(25 days)
- Interleukin 6, ng/L(25 days)
- Fibrinogen, mg/dL(25 days)
- Insulin sensitivity(25 days)