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Establishment of ketogenic diet therapy guidance in Japanese patients with ADPKD

Establishment of ketogenic diet therapy guidance in Japanese patients with ADPKD - Ketogenic diet therapy in Japanese ADPKD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052907
Enrollment
100
Registered
2023-11-27
Start date
2023-12-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autosomal dominant polycystic kidney

Interventions

Change diet to plant-focused diet supported by KetoCitra. Continue with the same dietary habits.

Sponsors

Department of Urology, Juntendo University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Male or female, 18 years of age or older (2) Have a confirmed diagnosis of ADPKD based on ADPKD guidelines (3) Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 at screening (according to [CKD-EPI] formula) (4) Female participants are not pregnant or lactating or planning to become pregnant or lactating during the study period (5) Able to read, understand, and respond to the survey form (6) Have no problems with the web environment and are able to take online classes. Also, able to complete the form online (7) Have voluntary written consent to participate in the study

Exclusion criteria

Exclusion criteria: (1) poorly controlled diabetes mellitus with HbA1C > 8.0 (2) Uncontrolled dyslipidemia with LDL cholesterol > 4 mmol/L or triglycerides > 3 mmol/L (3) Uncontrolled hypertension (SBP > 160 and/or BP > 100 mm Hg on 3 occasions) (5) Hyperkalemia (>5.5 mmol/l). (6) Significant disease such as malignancy within the past 5 years, autoimmune disease under immunosuppressive treatment (8) On any medication (SGLT2 inhibitor) or investigational drug that may affect the safety of the ketogenic diet (since bardoxolone methyl for ADPKD is under investigation in Japan). (12) Food sensitivities or allergies incompatible with the nutritional program (13) Subject is already compliant with a ketogenic diet or fasting (14) Current or past history of eating disorders or eating behaviors (16) Ulcerative colitis, irritable bowel syndrome, Crohn's disease, or gallbladder disease (17) BMI less than 18

Design outcomes

Primary

MeasureTime frame
Health status assessment (baseline and 3, 6, 9, and 12 months) Height, weight, BMI, abdominal circumference, blood pressure Blood samples (blood count, biochemistry; BUN, Cre, AST, ALT, LDH, ALP, T-Bil, D-Bil, fasting blood sugar, total-LDL-HDL-cholesterol, TG, HbA1c, CRP, adiponectin, leptin, ghrelin) Urine (specific gravity, PH, protein, ketone bodies, white blood cells, red blood cells, glucose, creatinine, Na, Pi) Height-adjusted total kidney volume (hTKV) from MRI or other imaging studies (at baseline and 12 months only, not exceeding the range of actual clinical kidney volume measurements) (Not to exceed the range of actual clinical renal volume measurements at baseline and 12 months only) Home measurements of blood ketone levels, blood glucose levels, and urinary Ph: daily for 1-12 weeks, weekly thereafter. Only these three items will be collected at home. Only these three items will be collected at home, and the others at the hospital.

Countries

Japan

Contacts

Public ContactHaruna Kawano

Juntendo University Graduate School of Medicine Department of Urology

harunase@juntendo.ac.jp0338133111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026