Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Finger Stick Glucose
研究概览
简要总结
This is a prospective study to determine ketogenic diet effect on htTKV, GFR, microalbuminuria. This is a single-center study of 20 patients with ADPKD and deemed high risk for progression to ESRD. This determined by combination of features of ADPKD and htTKV as assessed by prior computed tomography (CT) or MRI. Patients will be recruited from the Polycystic Kidney Disease (PKD) Clinic at Ohio State University Wexner Medical Center. Enrolled patients will have MRI for htTKV, urinary studies, blood tests at baseline, 6 months, and 52 weeks. Blood for GFR will be assessed three times over the course of the study including baseline, 6 months, and 1 year. Participants will follow ketogenic diet for 52 weeks. Investigatory diet team will manage the ketogenic diet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Age 18-65 years old
- •Diagnosis of ADPKD by imaging and/or genetic testing
- •GFR ≥ 25 mg/dl
- •Patients at risk for rapid progression of ADPKD: Mayo Class 1C-1E along with any other high risk features including early decline in GFR, hypertension onset ≤ 35 years of age, urologic events ≤ 35 years of age, PKD 1 truncating mutation and PROPKD score of 4 or higher as determined by the treating physician
- •No changes of medications within the last three months.
- •Able to comply with dietary intervention
- •Ability to sign informed consent
排除标准
- •Patients currently being treated with Tolvaptan
- •Diagnosed with diabetes.
- •Pregnancy
- •Contraindications to MRI
- •Ketogenic diet within the last three months
- •Severe kidney disease with GFR < 25 mg/dl
- •Unable to purchase food for the diet intervention
- •Gastrointestinal disorders that will interfere with diet intervention
- •Chronic alcohol or drug abuse
研究组 & 干预措施
Ketogenic Diet
The KD will follow general principles the investigators have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
干预措施: Ketogenic Diet (Other)
Ketogenic Diet
The KD will follow general principles the investigators have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
干预措施: Ketone/Glucose Monitoring (Biological)
Ketogenic Diet
The KD will follow general principles the investigators have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
干预措施: CGM/CKM (Biological)
Ketogenic Diet
The KD will follow general principles the investigators have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
干预措施: Blood Draw (Biological)
Ketogenic Diet
The KD will follow general principles the investigators have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
干预措施: Body Composition (Other)
Ketogenic Diet
The KD will follow general principles the investigators have described with the aim to achieve blood ketones >0.5 mM, which will require most participants to consume <50 g/day carbohydrate and ~1.5 g/kg reference weight protein. Fat will comprise the remaining calories with an emphasis on monounsaturated and saturated sources from whole foods.
干预措施: Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) . (Other)
结局指标
主要结局
Finger Stick Glucose
时间窗: Up to ~ 52 Weeks
changes in fasting glucose levels.
Finger Stick Beta-Hydroxybutyrate
时间窗: Up to ~ 52 Weeks
changes in fasting ketone levels.
次要结局
- Blood Pressure(Time Frame: Up to ~ 12 Weeks)