精心配制的生酮饮食 多囊肾病
精心配制的生酮饮食在延缓多囊肾病快速进展风险患者进展方面的可行性和功效
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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Madison L Kackley, PhD
- 电话号码:6142479650
- 邮箱:kackley.19@osu.edu
研究联系人备份
- 姓名:Jeff Volek, PhD
- 电话号码:6142926488
- 邮箱:volek.1@osu.edu
学习地点
-
-
Ohio
-
Columbus、Ohio、美国、43210
- 招聘中
- The Ohio State University
-
接触:
- Jeff Volek, PhD
- 电话号码:6146881701
- 邮箱:volek.1@osu.edu
-
接触:
- Madison L Kackley, PhD
- 电话号码:740-817-1622
- 邮箱:kackley.19@osu.edu
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:基础科学
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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. |
The diet intervention will start after all baseline testing is complete KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence. Continuous Ketone/Glucose Monitor will be applied at the start of Test Day 1. The sensor will be checked by the study team at each test day and will be removed and replaced by a fresh sensor at ~2- week intervals during the study. The sensor will be removed at the end of the final test day. Blood samples will be collected according to the schedule in Figure 1 DEXA Scanning will be done pre-, mid-, and post- intervention. Changes in glomerular filtration rate will be assessed via magnetic resonance imagining conducted by trained professionals. MRI imaging analyses will determine cardiac function. Trained imaging professionals will analyze the images to determine overall change (mg/mmol). |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Finger Stick Beta-Hydroxybutyrate
大体时间:Up to ~ 52 Weeks
|
changes in fasting ketone levels. |
Up to ~ 52 Weeks
|
|
Finger Stick Glucose
大体时间:Up to ~ 52 Weeks
|
changes in fasting glucose levels. |
Up to ~ 52 Weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Blood Pressure
大体时间:Time Frame: Up to ~ 12 Weeks
|
Changes in both Systolic and Diastolic blood pressure will be measured at each lab visit (eg. Baseline, Week 6, and Week 12). Recording: The systolic and diastolic pressures are recorded in millimeters of mercury (mmHg). For example, a reading of "120/80 mmHg" indicates a systolic pressure of 120 mmHg and a diastolic pressure of 80 mmHg. |
Time Frame: Up to ~ 12 Weeks
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2023H0258
- CDMRP-PR212399-G (其他赠款/资助编号:Departent of Defense)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.