Status:
UNKNOWN
Treat Autosomal Dominant Polycystic Kidney Disease With Oral Ketone Ester?
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
ADPKD
Eligibility:
All Genders
16-70 years
Phase:
PHASE2
Brief Summary
The investigators are running a study to see if a special drink, called a "ketone ester", can help people with a type of kidney disease named "Autosomal Dominant Polycystic Kidney Disease" or ADPKD fo...
Eligibility Criteria
Inclusion
- \- ADPKD patients (diagnosis based on genetics or imaging) ≥ 16 and ≤ 70 years.
- Total Kidney Volume ≥ 600 mL.
- eGFR (CKD-EPI) ≥ 30 ml/min/1.73m2.
- Normal blood glucose, HbA1C and ketones.
- Women of childbearing potential who are non-lactating and using an effective form of birth control.
- Stable disease-modifying treatment for the last 2 months.
- Well controlled hypertension (stable antihypertensive medications for at least 2 months).
- BMI \> 18 \< 30.
- Written informed consent.
Exclusion
- Exposure to a ketogenic diet or intermittent fasting for more than 2 weeks within 6 months before inclusion.
- Significant weight-loss (\> 10%) within 6 months before inclusion.
- Diabetes mellitus.
- Conditions prohibiting the use of a ketogenic diet (liver damage, pancreatic failure, pyruvate-carboxylase deficiency, defects in fatty acid oxidation/gluconeogenesis/ketolysis/neogenesis, hyperinsulinism), based on patient history.
- Diagnosis with any disorder of fatty acid metabolism based on patient history.
- Eating disorder.
- Alcohol abuse.
- Contraindication for MRI.
- Participation in other interventional trial.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06100133
Start Date
November 1 2023
End Date
July 1 2025
Last Update
October 25 2023
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