IL-1RA, Acute Exercise, and Beta-cell Function
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Beta-cell function
研究概览
简要总结
Subjects (N=48) with poorly-controlled type 2 diabetes (HbA1c>7%) will be assigned to one of the 4 following interventions in a randomised, parallel group design: [I] Control (placebo injection; no exercise), [II] Anakinra (100 mg subcutaneous injection of human recombinant interleukin-1 receptor antagonist), [III] Exercise (1 h cycle ergometry at 75% VO2max), [IV] Anakinra + Exercise. Pancreatic beta-cell function (plasma insulin responses) will be measured before and after each intervention using a hyperglycemic clamp (5.4 mM above basal glucose) combined with GLP-1 infusion (0.5 pmol/kg/min) and arginine injection (5 g bolus).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes with HbA1c >7%
排除标准
- •HbA1c >7%
- •Age <30 or >80 y
- •BMI <25 or >40 kg/m2
- •Pregnancy
- •Evidence of chronic haematological/renal/hepatic/pulmonary/heart disease
- •>2kg weight change in prior 6 months
- •Alcohol consumption (men: >14 drinks/week; women: >7 drinks/week)
- •Physical activity of >150 min/week
- •Contraindication to exercise
- •Contraindication to use of anakinra
研究组 & 干预措施
Anakinra + Exercise (ANEX)
100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus followed by 1 hour of cycling exercise at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
干预措施: Anakinra (AN) (Drug)
Anakinra + Exercise (ANEX)
100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus followed by 1 hour of cycling exercise at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
干预措施: Exercise (EX) (Behavioral)
Control (CON)
Placebo will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.
干预措施: Control (CON) (Behavioral)
Anakinra (AN)
100 mg of Kineret (Anakinra) will be administered as a subcutaneous injectable bolus, the day prior to the repeated measurement of beta-cell function.
干预措施: Anakinra (AN) (Drug)
Exercise (EX)
1 hour of cycling exercise will be performed at 75% VO2max, the day prior to the repeated measurement of beta-cell function.
干预措施: Exercise (EX) (Behavioral)
结局指标
主要结局
Beta-cell function
时间窗: 1 day after intervention
A hyperglycemic clamp will be performed combined with glucagon-like peptide(GLP)-1 infusion and arginine injection. The primary outcome is the insulin secretory response to glucose, GLP-1, and arginine.
次要结局
- Glucose disposition(1 day after intervention)
研究者
Thomas Solomon
Associate Professor
Rigshospitalet, Denmark