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NCT06325644 · ClinicalTrials.gov registry record · NA
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
A NA study of Polycystic Kidney Disease, sponsored by Ohio State University.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06325644: Recruiting NA study of Polycystic Kidney Disease, sponsored by Ohio State University.
NCT06325644 is a NA study of Polycystic Kidney Disease that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 20 participants, below the 329-participant average among 5 other Polycystic Kidney Disease trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06325644, a NA study of Polycystic Kidney Disease, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
changes in fasting ketone levels.
Conditions Studied
Interventions
- BIOLOGICAL Blood Draw
- OTHER Ketogenic Diet
- BIOLOGICAL Ketone/Glucose Monitoring
- BIOLOGICAL CGM/CKM
- OTHER Body Composition
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-06-01 |
| Est. Completion | 2027-04-01 |
| Phase | NA |
What NCT06325644 shows while recruiting
NCT06325644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 329-participant average among 5 other Polycystic Kidney Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Polycystic Kidney Disease appearing as the primary indexed condition, and to 5 interventions - of which Blood Draw is the first listed.
NCT06325644 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06325644 about?
NCT06325644 is a clinical study titled "Well-Formulated Ketogenic Diet Polycystic Kidney Disease". 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...
What is the current status of trial NCT06325644?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-06-01. Estimated completion is 2027-04-01.
What conditions does trial NCT06325644 study?
This clinical trial studies the following conditions: Polycystic Kidney Disease.
What interventions are being tested in trial NCT06325644?
The interventions under investigation include: Blood Draw (BIOLOGICAL), Ketogenic Diet (OTHER), Ketone/Glucose Monitoring (BIOLOGICAL), CGM/CKM (BIOLOGICAL), Body Composition (OTHER).
Who is sponsoring clinical trial NCT06325644?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06325644 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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