Short Term Induction of Ketosis in PKD
RESET-PKD
1 other identifier
interventional
10
1 country
1
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 a short period of time. The present study aims to investigate the effects of short term ketosis on total kidney volume (TKV) (and other parameters) in 10 ADPKD-patients with rapidly progressive disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedFirst Posted
Study publicly available on registry
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedSeptember 14, 2021
September 1, 2021
1 year
June 9, 2020
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative difference of TKV immediately before and after the ketonic state
MRI-based kidney volumetry at study visit 2 and study visit 3
Visit 2: 2-4 Weeks after enrolment; Visit 3: 3 - 21 days after Visit 2
Secondary Outcomes (27)
Absolute and relative difference of TKV
Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of height-adjusted total kidney volume (htTKV)
Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of total liver volume (TLV)
Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of cystic burden of kidneys and liver
Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative change of Renal Function Panel
Baseline visit (V1), study visit 2 (V2): 2-4 Weeks after enrolment; Visit 3: 3 - 21 days after Visit 2, and final study visit (V4) after at maximum 95 days
- +22 more secondary outcomes
Other Outcomes (10)
Changes of renal functional panel in 24-h-urine
Baseline and during 14 days of ketogenic diet or 3 days fasting
Changes of electrolytes and minerals in 24-h-urine
Baseline and during 14 days of ketogenic diet or 3 days fasting
Changes of glucose in 24-h-urine
Baseline and during 14 days of ketogenic diet or 3 days fasting
- +7 more other outcomes
Study Arms (2)
Fasting arm
EXPERIMENTALParticipants will be fasting during 72 hours
Diet arm
EXPERIMENTALParticipants will be using ketogenic diet for 14 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department II of Internal Medicine, University Hospital Cologne
Cologne, 50937, Germany
Related Publications (1)
Torres JA, Kruger SL, Broderick C, Amarlkhagva T, Agrawal S, Dodam JR, Mrug M, Lyons LA, Weimbs T. Ketosis Ameliorates Renal Cyst Growth in Polycystic Kidney Disease. Cell Metab. 2019 Dec 3;30(6):1007-1023.e5. doi: 10.1016/j.cmet.2019.09.012. Epub 2019 Oct 17.
PMID: 31631001BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roman-Ulrich Müller, Prof.
Department II of Internal Medicine, University of Cologne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department II of Internal Medicine
Study Record Dates
First Submitted
June 9, 2020
First Posted
July 15, 2020
Study Start
July 1, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share