Effect of Pioglitazone on Pancreatic Steatosis and Bone Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pancreatic Fat Content
研究概览
简要总结
Randomized, double blind, placebo controlled trial evaluating the effect of pioglitazone on pancreatic fat content and bone turnover markers.
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
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fat level in the pancreas above 4% (measurement done by us with an MRI)
- •English speaker
- •over 21 years old
排除标准
- •contraindication to MRI
- •pregnancy or desire to conceive
- •use of unapproved medications
- •prior pancreatic disease
- •use of more then 2 alcoholic drinks every day
研究组 & 干预措施
pioglitazone
pioglitazone tablet 45 mg once daily
干预措施: pioglitazone (Drug)
placebo pill
placebo pill once daily (look-alike pill which contains no active ingredients)
干预措施: placebo (Drug)
结局指标
主要结局
Pancreatic Fat Content
时间窗: 12 months
Pancreatic fat content was determined by proton magnetic resonance spectroscopy (1H-MRS) using a 1.5 Tesla Philips Intera system.
Bone Turnover Marker - Intact Parathyroid Hormone (PTH)
时间窗: 12 months
Intact parathyroid hormone (PTH) were measured using enzyme-linked immunosorbent assay. .
Bone Turnover Marker - Plasma 25-hydroxyvitamin D
时间窗: 12 months
Plasma 25-hydroxyvitamin D was determined by radioimmunoassay
次要结局
- Visceral Fat Area(12 months)
- Beta-cell Function(12 months)
- Hepatic Fat Content(12 months)
- Subcutaneous Fat Area(12 months)
- Bone Mineral Density(12 months)
- Disposition Index(12 months)
研究者
Ildiko Lingvay
MD, MPH, MSCS
University of Texas Southwestern Medical Center