NCT01285232Unknown不适用
The Effect of Interleukin-1 Receptor Antagonist on Insulin Secretion in Subjects With Beta Cell Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .
研究概览
简要总结
Rationale: Once diabetes develops, β-cell function progressively deteriorates and therapeutic approaches that prevent of delay loss of β-cell function are needed in the treatment of type 2 diabetes mellitus. Recent findings suggest that interleukin-1 (IL-1) may be involved in the progressive β-cell dysfunction in type 2 diabetes mellitus.
Objective: to determine whether blocking IL-1β by recombinant human IL-1ra (anakinra) improves beta-cell function in subjects with β-cell dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Impaired glucose tolerance assessed by oral glucose tolerance test and/or impaired fasting glucose ( ≥ 5.6 mmol/L) and/or HbA1c levels of 5.7-6.4%
- •BMI >25 kg/m2
- •Age 40-70 years
排除标准
- •Known diabetes mellitus
- •Fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5%
- •Immunodeficiency or immunosuppressive treatment (including TNFα blocking agents and corticosteroids)
- •Use of anti-inflammatory drugs ( including corticosteroids and non steroidal anti-inflammatory drugs, 100 mg or less of aspirin is allowed)
- •Signs of current infection (fever, C-reactive protein >30 mmol/L, treatment with antibiotics, previous or current diagnosis of tuberculosis)
- •A history of recurrent infections
- •Pregnancy or breastfeeding (contraception of at least 3 months before inclusion is required)
- •Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range
- •Renal disease defined as MDRD < 60 ml/min/1.73m2
- •Neutropenia < 2x 109/L
- •Inability to understand the nature and extent of the trial and the procedures required.
- •Any medical condition that might interfere with the current study protocol
- •Participation in a drug trial within 60 days prior to the first dose
研究组 & 干预措施
Anakinra
Experimental
Anakinra 150 mg/day during four weeks
干预措施: Anakinra (Drug)
Placebo
Placebo Comparator
Placebo during four weeks
干预措施: Anakinra (Drug)
结局指标
主要结局
To determine the effect of anakinra on insulin secretion, as derived from hyperglycemic clamps .
时间窗: after 4 weeks of treatment with anakinra
次要结局
- To determine the effect on anakinra on insulin sensitivity.(after 4 week treatment of anakinra)
- Effects of anakinra on fat cell morphology and gene expression(after 4 weeks of treatment with anakinra)
研究者
研究点 (1)
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