Status:
COMPLETED
Ketogenic Dietary Interventions in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead Sponsor:
University of Cologne
Conditions:
ADPKD
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
A mild reduction in food intake significantly inhibits renal cyst growth in mouse models of ADPKD. The underlying mechanism was unknown at the time. Recently published data show that the beneficial ef...
Eligibility Criteria
Inclusion
- Male and female ADPKD patients (based on genetics or imaging) ≥ 18 and ≤ 60 years
- Indicators of rapid progression, either of the following:
- Mayo class 1C-E (measured on screening)
- Truncating PKD1 mutation,
- onset of arterial hypertension/urological symptoms \< 35 years (patient history)
- first- or second degree family members reaching ESRD at \< 60 years of age (patient history),
- eGFR loss \> 2.5 ml/min/yr (as determined by at least 4 serum creatinine values within the last 4 years, with at least 6 months between each measurement ),
- PROPKD score \> 6 (patient history)
- CKD-stages G1-3 as determined by eGFR (CKD-EPI)
- Written informed consent
Exclusion
- Underweight or obese individuals ( as defined by BMI ≤ 18.5 kg/m2 or ≥ 35 kg/m2)
- Exposure to a ketogenic diet (classical ketogenic diet or modified Atkins)for more than 2 weeks within the last 6 months
- Participation in a weight-loss program within the last 6 months based on patient history
- Vegetarian / vegan lifestyle based on patient history
- Current treatment (or within the last 6 months) with tolvaptan or a somatostatin analogue based on patient history
- Inability to give informed consent
- 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 including Carnitine deficiency (primary), Carnitine palmitoyltransferase (CPT) I or II deficiency, Carnitine translocase deficiency, Beta-oxidation defects, Medium-chain acyl dehydrogenase deficiency (MCAD), Long-chain acyl dehydrogenase deficiency (LCAD), Short-chain acyl dehydrogenase deficiency (SCAD), Long-chain 3-hydroxyacyl-CoA deficiency, Medium-chain 3-hydroxyacyl-CoA deficiency, Pyruvate carboxylase deficiency based on patient history
- Eating disorder based on patient history (as defined by the assessment of the study physician)
- Alcohol abuse based on patient history (as defined by the assessment of the study physician)
- Type 1 diabetes mellitus based on patient history
- Insulin-dependent type 2 diabetes mellitus based on patient history
- Contraindication regarding the MRI exam e.g. non-MRI suitable implants ( including cardiac pacemakers, cochlear implants, aneurysm clip), claustrophobia, large tatoos with metal-containing ink
- Patients, who may be at risk from the blood loss due to scheduled blood draws at the discretion of the physician
- Pregnancy or breastfeeding
- Absence of safe contraceptive measures or non-occurrence of menopause (in women)
- Participation in other interventional trials
- Persons who are in a dependency/employment relationship with the investigators
- Accommodation in an institution by judicial or administrative order.
Key Trial Info
Start Date :
January 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04680780
Start Date
January 10 2021
End Date
August 12 2022
Last Update
August 24 2022
Active Locations (1)
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1
Department II of Internal Medicine, University Hospital of Cologne
Cologne, Germany, 50937