Effects of Pioglitazone on Adiponectin and Inflammatory Markers in Overweight or Obese Hemodialysis Patients: A Double-Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months
研究概览
简要总结
This is a double blinded randomized clinical trial of pioglitazone vs. placebo in overweight or obese, diabetic and non-diabetic hemodialysis patients. This study will examine whether pioglitazone modulates adipokine production by adipose tissue in hemodialysis patients and whether these changes result in reduction of inflammation, insulin resistance and oxidative stress and increase in muscle mass.
In addition, this study will also examine the associations of adiposity with adipokines and the metabolic milieu in hemodialysis patients to better understand the biology of adipocytes in uremic milieu.
详细描述
Randomization:
100 overweight or obese patients will be randomly allocated to oral pioglitazone 15 mg/d or placebo for two weeks by blocks of five using a random number generator and monitored for adverse events including hypoglycemia. If they tolerate the 15 mg pioglitazone or matching placebo for two weeks, participants will be assigned to 30 mg of pioglitazone or matching placebo for 24 more weeks. Those who received 15 mg of pioglitazone will receive 30 mg of pioglitazone for the next 24 weeks. Those who received placebo for initial 2 weeks will receive another placebo that matches the 30 mg pioglitazone pill for 24 weeks.
Baseline:
Participants will have fasting blood drawn for adipokines: Tumor Necrosis Factor-alpha (TNF-alpha), Interleukin-6 (IL-6), high sensitivity C-Reactive Protein (hsCRP), high molecular weight Adiponectin (HMW-A), and leptin. All patients will undergo MRI scans on the mid-week non-dialysis day. Twenty each of overweight/obese patients randomized to pioglitazone or placebo will also undergo subcutaneous fat biopsy on the mid-week non-dialysis day.
Study Period:
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
- •Overweight (Body Mass Index ≥ 25 kilograms per meter squared (kg/m2))
- •Adult (18 years or older)
- •Chronic hemodialysis patient
- •Diabetic (type 2) or insulin resistant
排除标准
- •<18 years old
- •No insulin resistance
- •Active liver disease
- •Class III or IV New York Heart Association heart failure
- •Macular edema or hard exudates near macula on fundoscopy
- •Current active malignancy (excluding squamous and basal cell skin cancers)
- •Active AIDS
- •Chronic lung disease requiring supplemental oxygen therapy
- •Enrolled in interventional trials using drugs or devices
- •Bone break of long bones, vertebrae, or hips in the past three years
研究组 & 干预措施
Pioglitazone
15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks
干预措施: Pioglitazone (Drug)
Placebo
1 placebo pill a day matching the pioglitazone treatment for 26 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in High Molecular Weight Adiponectin (HMW-A) Concentration in Plasma From Baseline to 6 Months
时间窗: Baseline and 6 months
The percent difference in HMW-A concentration geometric mean values from baseline to 6 months was calculated for each arm
Change in High Sensitivity C-Reactive Protein (hsCRP) Concentration in Plasma From Baseline to 6 Months
时间窗: Baseline and 6 months
The percent difference in hsCRP concentration geometric mean values from baseline to 6 months was calculated for each arm
次要结局
- Change in Tumor Necrosis Factor-α (TNF-α) Concentration in Plasma From Baseline to 6 Months(Baseline and 6 months)
- Change in Interleukin-6 (IL-6) Concentration in Plasma From Baseline to 6 Months(Baseline and 6 months)
研究者
Srinvasan Beddhu
MD, Associate Professor of Medicine
University of Utah