Di-PKD: A Pilot Trial of a 12-Month Targeted Dietary Intervention on Cyst Progression in Patients With Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression of kidney cysts by change in total kidney volume (TKV) from baseline to 12 months
研究概览
简要总结
The goal of this interventional study is to evaluate the impact of a specific diet (low salt, limited caffeine, high potassium, low phosphate, limited protein, limited carbohydrate intake, adequate water intake) on changes in serum and urinary biomarkers, total kidney volume (TKV), and cyst progression in subjects with autosomal dominant polycystic kidney disease (ADPKD).
Researchers will compare the results of subjects in the study diet (interventional) arm to the results of subjects in the regular diet (control) arm.
详细描述
15 subjects will be enrolled in each dietary arm for a total of 30 subjects. All subjects will follow the study diet for one week, after which serum and urinary biomarkers will be measured. A baseline evaluation, including genetic testing, MRI, Mayo Clinic Imaging Classification and 10-question survey will also be conducted. After Week 1 of the study, subjects will be assigned to the intervention or control arm. Subjects will have six follow-up visits at months 1, 2, 3, 6, 9 and 12 to assess adherence to diet. Serum and urinary biomarkers will be repeated at each visit. MRI will be repeated at Month 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of ADPKD
- •Genetic testing confirmation of PKD1 or PKD2
- •eGFR >30mL/1.73m2
- •Willingness to adhere to a preconditioning diet for 1 week and ability to complete the study
- •Mayo Clinic Imaging Classification (MCIC): 1C, 1D, 1E
排除标准
- •History of dietary non-adherence
- •Subjects on Tolvaptan
- •Comorbidities that could interfere with participation (Diabetes, Heart Failure (EF<30%) Advanced Chronic Kidney Disease (CKD) Stage 4 and higher)
研究组 & 干预措施
Interventional Diet
Subjects will follow a specified diet (low salt, limited caffeine, high potassium, low phosphate, and limited protein and carbohydrate intake along with adequate water intake) after 1 week of preconditioning for 12 months.
干预措施: Interventional Diet (Other)
Regular Diet
Subjects will follow the diet they normally adhere to after 1 week of preconditioning.
结局指标
主要结局
Progression of kidney cysts by change in total kidney volume (TKV) from baseline to 12 months
时间窗: Change between baseline and 12 months
A composite measurement of MRI to determine total kidney volume (TKV) by kidney length, width, and depth will be done at baseline and again at 12 months. MRI results will be compared between the two-time points to assess the cyst progression, if any. An increase of about 5% per year from baseline will be significant.
次要结局
- Progression of kidney cysts as evidenced by urinary biomarkers from baseline to 12 months(Change between baseline and 12 months)
- Progression of kidney cysts as evidenced by serum biomarkers from baseline to 12 months(Change between baseline and 12 months)