Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT06100133
Eligibility Criteria:
Inclusion Criteria:
* \- 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
70 Years
Study:
NCT06100133
Study Brief:
Protocol Section:
NCT06100133