Идёт набор NCT06325644

Well-Formulated Ketogenic Diet Polycystic Kidney Disease

Без фазы С лечением Polycystic Kidney Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Ketogenic Diet, Ketone/Glucose Monitoring, CGM/CKM, Blood Draw.
Кому может быть актуально: Состояния в реестре: Polycystic Kidney Disease. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility and Efficacy of a Well-Formulated Ketogenic Diet in Delaying Progression of Polycystic Kidney Disease in Patients at Risk for Rapid Progression

Обзор

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.

Вмешательства

Другое Ketogenic Diet
The diet intervention will start after all baseline testing is complete
Биопрепарат Ketone/Glucose Monitoring
KetoMojo hand-held glucometer will be used daily to monitor dietary intervention adherence.
Биопрепарат CGM/CKM
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.
Биопрепарат Blood Draw
Blood samples will be collected according to the schedule in Figure 1
Другое Body Composition
DEXA Scanning will be done pre-, mid-, and post- intervention.
Другое Change in glomerular filtration rate (mg/mmol) via magnetic resonance imaging (MRI) .
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).

Первичные конечные точки

Finger Stick Beta-Hydroxybutyrate [Срок оценки: Up to ~ 52 Weeks]
Finger Stick Glucose [Срок оценки: Up to ~ 52 Weeks]

Вторичные конечные точки (1)

Blood Pressure [Срок оценки: Time Frame: Up to ~ 12 Weeks]

Критерии участия

Критерии включения

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