ADPKDRESET-PKDNCT04472624
Short Term Induction of Ketosis in PKD
A study testing Fasting and Ketogenic diet in people with ADPKD, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ADPKD
- What is being tested?
- Fasting and Ketogenic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- ≥ 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department II of Internal Medicine, University Hospital Cologne
Cologne, 50937
About this study
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.
Read the 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 reduction, ad libitum administered ketogenic diet (KD) and acute short-term fasting in mouse, rat and feline models of PKD.
In a PKD rat model, TRF without caloric reduction resulted in a strong inhibition of mTOR signaling, proliferation and fibrosis in the affected kidneys. The adminstration of an ad libitum fed KD led to similar results. In rat, mouse and feline models of PKD, acute fasting led to a significant reduction of cyst volume. Therefore, cystic cells seem to be metabolically inflexible and exhibit an altered metabolism characterized by increased glycolysis and, amongst others, defective fatty acid oxidation, similar to the Warburg effect in cancer. (Torres, Kruger et al. 2019)
While those beneficial observations were made in mouse, rat and feline models of PKD, the effects of a ketogenic diet in human ADPKD patients have not been investigated yet, even though the adminstration of ketogenic diets is used as a treatment for epilepsy in children since the 1920s and fasting is one of the oldest medical procedures.
Therefore, the aim of the present study is to investigate the effects of a short-period ketonic state in 10 ADPKD patients with fast progressive disease.
10 ADPKD-patients (aged 18-60 years, CKD G 1-3a) will be enrolled after giving informed consent. These 10 subjects will go through four trial-related visits. During these visits, physical examinations will be performed, blood will be drawn, urine will be collected and ketone body measurements in breath, blood and urine will be carried out. Each study visit includes an abdominal MRI-scan. Between visit 1 and visit 2, patients will eat their regular carbohydrate-rich diet. After visit 2, a ketonic state will be induced in those patients. Patients can choose whether the ketonic state will be induced by acute fasting for 72 hours (under sufficient water consumption and salt substitution) or by eating a KD for 14 days. Study visit 3 will take place within 72 hours after finishing the dietary intervention. After study visit 3, patients will restart eating their regular diet. Study visit 4 will provide follow-up data 3-6 weeks after the dietary intervention.
After study completion, the relative difference of TKV measured by MRI-based volumetry of the kidneys immediately before and immediately after the ketonic state, will be compared to TKV growth/decline while eating a regular carbohydrate-rich diet.
In general, patients are counselled in our outpatient department as part of "The German AD(H)PKD Registry" (more than 700 patients enrolled). As from those patients, clinical data, laboratory data and imaging studies are present, identification and recruitment of patients with fast rapidly progressing disease will be facilitated. Also, the investigators are closely liaised with the German self-help group PKDCure (PKD Familiaere Zystennieren e.V.), which is dedicated to ADPKD-linked research. This will facilitate recruitment of patients even more.
Data obtained from the study visits will be collected. The parameters listed below constitute the core data set, additional parameters can be included if considered essential.
Registered patients will be provided with diaries for the documentation of feeling of hunger, problems and discomforts as well as acetoacetate concentrations in breath. Patients are also provided with a portable breath-analyzer to measure acetoacetate concentrations in breath in between study visits. Study diaries are collected on Visit 4.
Data capture will be performed at each study visit after enrollment.
- Conditions
- ADPKD
- Being tested
- Fasting, Ketogenic diet
- Keywords
- ADPKD, dietary intervention, ketosis, fasting, ketogenic diet
- Medical subject headings
- Polycystic Kidney, Autosomal Dominant, Ketosis, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Acute fasting for 72 hours
Ketogenic dietOther
Intake of a ketogenic diet for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Fasting arm | Experimental | Participants will be fasting during 72 hours Receives: Other: Fasting |
| Diet arm | Experimental | Participants will be using ketogenic diet for 14 days Receives: Other: Ketogenic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative difference of TKV immediately before and after the ketonic state
MRI-based kidney volumetry at study visit 2 and study visit 3
Measured: Visit 2: 2-4 Weeks after enrolment; Visit 3: 3 - 21 days after Visit 2
Secondary outcomes (27)
Absolute and relative difference of TKV
assessed by MRI-based volumetry at all study visits
Measured: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of height-adjusted total kidney volume (htTKV)
assessed by MRI-based volumetry at all study visits
Measured: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of total liver volume (TLV)
assessed by MRI-based volumetry at all study visits
Measured: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of cystic burden of kidneys and liver
assessed by MRI at all study visits
Measured: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative change of Renal Function Panel
Measurement of creatinine, urea and uric acid in blood and urine samples (measurement unit mg/dl)
Measured: 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
Absolute and relative change of electrolytes and minerals
Measurement of electrolyte and minerals (sodium, natrium, potassium, magnesium, chloride, phosphate) in blood (measurement unit mmol/L) and urine samples (measurement unit mmol/24h)
Measured: 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
Absolute and relative change of albumin
Measurement in blood and urine samples
Measured: 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
Absolute and relative change of glucose
Measurement in blood and urine samples
Measured: 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
Absolute and relative change of Hepatic Function Panel
Measurement of Alanine aminotransferase(ALT), Aspartate Aminotransferase (ASP), Alkaline Phosphatase (ALP), gamma-glutamyl transferase (GGT) and Lactate Dehydrogenase (LD) in blood samples (measurement unit U/L)
Measured: 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
Absolute and relative change of bilirubin
Measurement in blood samples
Measured: 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
Absolute and relative change of lipid panel
Measurement of high density lipoprotein (HDL), low density lipoprotein (LDL), total cholesterol, triglycerides and lipoprotein(a) in blood samples
Measured: 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
Absolute and relative change of inflammatory parameters
Measurement of c-reactive protein (CRP) and high sensitivity c-reactive protein (hsCRP) in blood samples ( measurement unit mg/L)
Measured: 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
Absolute and relative change in blood count
Measurement of white blood cells, red blood cells, platelets in blood samples (measurement unit 10^9/L )
Measured: 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
Absolute and relative change of hemoglobin
Measurement in blood samples
Measured: 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
Absolute and relative change of hematokrit
Measurement in blood samples
Measured: 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
Absolute and relative change of betahydroxybutyrate level
Measurement of betahydroxybutyrate level in blood samples for determination of ketosis
Measured: 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
Absolute and relative change in blood gas analysis
Measurement with blood gas analyzer for determination of ketosis
Measured: 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
Analysis of the ketonic state with betahydroxybutyrate level
Betahydroxybutyrate measurement from blood samples of the fingertip by patients at home
Measured: Baseline visit (V1), during 14 days of ketogenic diet or 3 days fasting and final study visit (V4) after at maximum 95 days
Analysis of the ketonic state with ketonuria
Ketonuria measured with urine stix by patients at home
Measured: Baseline visit (V1), during 14 days of ketogenic diet or 3 days fasting and final study visit (V4) after at maximum 95 days
Analysis of the ketonic state with acetoacetate in breath
determination of acetoacetate in breath by patients at home
Measured: Baseline visit (V1), during 14 days of ketogenic diet or 3 days fasting and final study visit (V4) after at maximum 95 days
Absolute and relative change of height
Determination of height
Measured: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Absolute and relative change of weight
Determination of weight
Measured: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Absolute and relative change of waist circumference
Determination of waist circumference
Measured: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Relative change of calorimetry
Could be determined instead of anthropometric parameters
Measured: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Changes in Bioimpedance
Bioimpedance measurements on each visit
Measured: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Feeling of hunger, discomforts and problems
measured and documented at home in a study dietary in between study visits
Measured: In between baseline visit (V1) and final study visit (V4) after at maximum 95 days
Acetoacetate-concentrations
measured and documented at home in a study dietary in between study visits
Measured: In between baseline visit (V1) and final study visit (V4) after at maximum 95 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADPKDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Müller, University of Cologne
- Investigators
- Roman-Ulrich Müller, Prof., Principal investigator, Department II of Internal Medicine, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472624
- Sponsor's protocol ID
- 20-1040
- Acronym
- RESET-PKD
- Status last verified
- Sep 2021
- First submitted
- 9 Jun 2020
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31631001
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Induction of Ketosis in PKD
- ClinicalTrials.gov ID
- NCT04472624
- Acronym / sponsor ID
- RESET-PKD / 20-1040
- Conditions
- ADPKD
- Keywords
- ADPKD, dietary intervention, ketosis, fasting, ketogenic diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 reduction, ad libitum administered ketogenic diet (KD) and acute short-term fasting in mouse, rat and feline models of PKD.
In a PKD rat model, TRF without caloric reduction resulted in a strong inhibition of mTOR signaling, proliferation and fibrosis in the affected kidneys. The adminstration of an ad libitum fed KD led to similar results. In rat, mouse and feline models of PKD, acute fasting led to a significant reduction of cyst volume. Therefore, cystic cells seem to be metabolically inflexible and exhibit an altered metabolism characterized by increased glycolysis and, amongst others, defective fatty acid oxidation, similar to the Warburg effect in cancer. (Torres, Kruger et al. 2019)
While those beneficial observations were made in mouse, rat and feline models of PKD, the effects of a ketogenic diet in human ADPKD patients have not been investigated yet, even though the adminstration of ketogenic diets is used as a treatment for epilepsy in children since the 1920s and fasting is one of the oldest medical procedures.
Therefore, the aim of the present study is to investigate the effects of a short-period ketonic state in 10 ADPKD patients with fast progressive disease.
10 ADPKD-patients (aged 18-60 years, CKD G 1-3a) will be enrolled after giving informed consent. These 10 subjects will go through four trial-related visits. During these visits, physical examinations will be performed, blood will be drawn, urine will be collected and ketone body measurements in breath, blood and urine will be carried out. Each study visit includes an abdominal MRI-scan. Between visit 1 and visit 2, patients will eat their regular carbohydrate-rich diet. After visit 2, a ketonic state will be induced in those patients. Patients can choose whether the ketonic state will be induced by acute fasting for 72 hours (under sufficient water consumption and salt substitution) or by eating a KD for 14 days. Study visit 3 will take place within 72 hours after finishing the dietary intervention. After study visit 3, patients will restart eating their regular diet. Study visit 4 will provide follow-up data 3-6 weeks after the dietary intervention.
After study completion, the relative difference of TKV measured by MRI-based volumetry of the kidneys immediately before and immediately after the ketonic state, will be compared to TKV growth/decline while eating a regular carbohydrate-rich diet.
In general, patients are counselled in our outpatient department as part of "The German AD(H)PKD Registry" (more than 700 patients enrolled). As from those patients, clinical data, laboratory data and imaging studies are present, identification and recruitment of patients with fast rapidly progressing disease will be facilitated. Also, the investigators are closely liaised with the German self-help group PKDCure (PKD Familiaere Zystennieren e.V.), which is dedicated to ADPKD-linked research. This will facilitate recruitment of patients even more.
Data obtained from the study visits will be collected. The parameters listed below constitute the core data set, additional parameters can be included if considered essential.
Registered patients will be provided with diaries for the documentation of feeling of hunger, problems and discomforts as well as acetoacetate concentrations in breath. Patients are also provided with a portable breath-analyzer to measure acetoacetate concentrations in breath in between study visits. Study diaries are collected on Visit 4.
Data capture will be performed at each study visit after enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting arm | Experimental | Other: FastingParticipants will be fasting during 72 hours |
| Diet arm | Experimental | Other: Ketogenic dietParticipants will be using ketogenic diet for 14 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Male and female ADPKD-patients (diagnosed by genetics / typical MRI / ultrasound)
- With evidence of fast progression, at least one of the following criteria
- Age ≥ 18 and ≤ 60 years
- CKD stage 1-3a according to eGFR
- Signed written informed consent
Key exclusion criteria (19 listed)
- Currently under tolvaptan
- BMI < 18 or > 35
- Diabetes mellitus (Type I, Type II, MODY, LADA)
- Active alcoholism
- Vegan or vegetarian lifestyle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingAcute fasting for 72 hours | Other | Fasting arm |
| Ketogenic dietIntake of a ketogenic diet for 14 days | Other | Diet arm |
Primary outcome
Relative difference of TKV immediately before and after the ketonic state
Time frame: Visit 2: 2-4 Weeks after enrolment; Visit 3: 3 - 21 days after Visit 2
MRI-based kidney volumetry at study visit 2 and study visit 3
27 secondary outcomes
Absolute and relative difference of TKV
Time frame: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of height-adjusted total kidney volume (htTKV)
Time frame: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of total liver volume (TLV)
Time frame: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative difference of cystic burden of kidneys and liver
Time frame: Baseline visit (V1) and final study visit (V4) after at maximum 95 days
Absolute and relative change of Renal Function Panel
Time frame: 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
Absolute and relative change of electrolytes and minerals
Time frame: 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
Absolute and relative change of albumin
Time frame: 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
Absolute and relative change of glucose
Time frame: 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
Absolute and relative change of Hepatic Function Panel
Time frame: 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
Absolute and relative change of bilirubin
Time frame: 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
Absolute and relative change of lipid panel
Time frame: 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
Absolute and relative change of inflammatory parameters
Time frame: 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
Absolute and relative change in blood count
Time frame: 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
Absolute and relative change of hemoglobin
Time frame: 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
Absolute and relative change of hematokrit
Time frame: 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
Absolute and relative change of betahydroxybutyrate level
Time frame: 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
Absolute and relative change in blood gas analysis
Time frame: 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
Analysis of the ketonic state with betahydroxybutyrate level
Time frame: Baseline visit (V1), during 14 days of ketogenic diet or 3 days fasting and final study visit (V4) after at maximum 95 days
Analysis of the ketonic state with ketonuria
Time frame: Baseline visit (V1), during 14 days of ketogenic diet or 3 days fasting and final study visit (V4) after at maximum 95 days
Analysis of the ketonic state with acetoacetate in breath
Time frame: Baseline visit (V1), during 14 days of ketogenic diet or 3 days fasting and final study visit (V4) after at maximum 95 days
Absolute and relative change of height
Time frame: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Absolute and relative change of weight
Time frame: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Absolute and relative change of waist circumference
Time frame: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Relative change of calorimetry
Time frame: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Changes in Bioimpedance
Time frame: Baseline visit (V1), V2 (2-4 Weeks after enrolment); Visit 3 (3 - 21 days after Visit 2 ) and final study visit (V4) after at maximum 95 days
Feeling of hunger, discomforts and problems
Time frame: In between baseline visit (V1) and final study visit (V4) after at maximum 95 days
Acetoacetate-concentrations
Time frame: In between baseline visit (V1) and final study visit (V4) after at maximum 95 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Background: PubMed 31631001Torres 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roman-Ulrich Müller, Prof. principal investigator
Department II of Internal Medicine, University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and Ketogenic diet in people with ADPKD, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative difference of TKV immediately before and after the ketonic state (time frame: Visit 2: 2-4 Weeks after enrolment; Visit 3: 3 - 21 days after Visit 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04472624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.