Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β- The Hyper-PreDIL-Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in insulin concentration following a standardized mixed-meal test
研究概览
简要总结
The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®).
The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with prediabetes defined by HbA1c 5.7-6.4 % or fasting plasma glucose 6.1-6.9 mmol/l or plasma glucose 2 h following 75g glucose ingestion of 7.8-11.0 mmol/l.
- •BMI ≥ 28 kg/m2
- •Age ≥ 18 years
- •C-reactive protein ≥ 2 mg/dl
- •For subjects with reproductive potential, willingness to use contraceptive measures adequate to prevent the subject from becoming pregnant during the study
排除标准
- •Upper gastrointestinal surgery
- •Diagnosis of any type of diabetes mellitus
- •Signs of current infection
- •Use of any glucose lowering medication within the last three months
- •Use of investigational drug up to one week prior to start of treatment phase.
- •Anti-inflammatory medication, including systemic glucocorticoid therapy.
- •Neutropenia (leukocyte count < 1.5 × 109/L or absolute neutrophil count (ANC) < 0.5 × 109/L)
- •Anemia (hemoglobin < 11 g/dL for males, < 10 g/dL for females)
- •Clinically significant kidney or liver disease (creatinine > 1.5 mg/dL, aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2 × ULN, alkaline phosphatase > 2 × ULN, or total bilirubin [tBili] > 1.5 × ULN)
- •Uncontrolled disease
- •Currently pregnant or breastfeeding
- •No subjects meeting the criteria for vulnerability. Participation in another study with investigational drug within the 30 days preceding and during the present study
研究组 & 干预措施
Experimental Intervention
Patients receive investigational product
干预措施: Anakinra (Drug)
Control Intervention
Patients receive placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in insulin concentration following a standardized mixed-meal test
时间窗: two time assessment at baseline and after 1-2 weeks
Changes in insulin concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
Change in glucose concentration following a standardized mixed-meal test
时间窗: two time assessment at baseline and after 1-2 weeks
Changes in glucose concentration (mmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
Change in c-peptide concentration following a standardized mixed-meal test
时间窗: two time assessment at baseline and after 1-2 weeks
Changes in c-peptide concentration (nmol/l) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
Change in insulinogenic index (IGI) concentration following a standardized mixed-meal test
时间窗: two time assessment at baseline and after 1-2 weeks
Changes in insulinogenic index (IGI) (I30 - I0)/(G30 - G0) under anakinra compared to placebo. Blood will be analysed 90 and 0 min before and 30 min, 1 hr, 1.5 hrs, 2 hrs, 2.5 hrs, 3 hrs after the mixed meal.
次要结局
未报告次要终点