Status:
COMPLETED
Short Term Induction of Ketosis in PKD
Lead Sponsor:
University of Cologne
Conditions:
ADPKD
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Recently, it has been shown that ketose-inducing dietary interventions slow disease progression in animal models of polycystic kidney disease (PKD), even when the state of ketosis is only induced for ...
Detailed Description
Recently, dietary models inducing ketosis have been shown to inhibit disease progression in animal models of PKD. Those beneficial dietary models included time-restricted feeding (TRF) without caloric...
Eligibility Criteria
Inclusion
- Male and female ADPKD-patients (diagnosed by genetics / typical MRI / ultrasound)
- With evidence of fast progression, at least one of the following criteria
- Mayo Class 1C-1E
- Truncating PKD1-mutation
- Hypertension \< 35 years
- Urological complications \< 35 years
- ≥ 1 first class or second class family member with need of renal replacement therapy \< 60 years
- eGFR loss \> 2,5 ml/min/1,73m2 per year
- PROPKD-Score \> 6
- Age ≥ 18 and ≤ 60 years
- CKD stage 1-3a according to eGFR
- Signed written informed consent
Exclusion
- Currently under tolvaptan
- BMI \< 18 or \> 35
- Diabetes mellitus (Type I, Type II, MODY, LADA)
- Active alcoholism
- Vegan or vegetarian lifestyle
- Inability to sign or understand written informed consent
- Anamnestically known circumstances which forbid the induction of a ketonic state by ketogenic diet or acute fasting (Liver damage (AST/ALT \> 3x upper limit of normal, alkaline phosphatase \> 6x upper limit of normal , Bilirubin ≥ 3 mg/dl), Diabetes mellitus, Pyruvate carboxylase deficiency, defects of gluconeogenesis, defects of ketolysis / ketogenesis, hyperinsulinism, defects of fatty acid oxidation )
- Allergies or food intolerance against components of a ketogenic diet
- Eating disorders (Anorexia nervosa / Bulimia)
- Participation in a weight loss program (e.g. Optifast) or intake of medication to promote weight loss within the last six months
- Ketogenic Diet \> 1 month within the last 12 months
- Chronic renal replacement therapy
- Previous history of kidney transplantation
- Uncontrolled local or systemic infection (according to clinical assessment)
- Simultaneous participation in other interventional studies
- Pregnant or breastfeeding women
- Persons who are dependent of or employed by the study investigators
- Contraindications against MRI examinations (stents, pacemakers or other metal inserts, claustrophobia)
- Persons living in an establishment by court order or official instructions
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04472624
Start Date
July 1 2020
End Date
July 1 2021
Last Update
September 14 2021
Active Locations (1)
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1
Department II of Internal Medicine, University Hospital Cologne
Cologne, Germany, 50937