Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- C-peptide response to a Sustacal meal
研究概览
简要总结
A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.
详细描述
Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes mellitus diagnosed within 4 months
- •Age > 6 years of age
- •Ability to swallow capsule
- •Signed informed consent / assent
排除标准
- •Other illnesses
研究组 & 干预措施
Pioglitazone
干预措施: pioglitazone (Drug)
Pioglitazone
干预措施: Placebo control (Drug)
Placebo control
干预措施: pioglitazone (Drug)
Placebo control
干预措施: Placebo control (Drug)
结局指标
主要结局
C-peptide response to a Sustacal meal
时间窗: 6 months
次要结局
- Insulin requirement(6 months)
- Hemoglobin A1c(6 months)
研究者
Thomas A. Wilson
Professor of Pediatrics
Stony Brook University