Establishment of ketogenic diet therapy guidance in Japanese patients with ADPKD

Not Applicable

• Conditions: Autosomal dominant polycystic kidney

• Registration Number: JPRN-UMIN000052907
• Lead Sponsor: Department of Urology, Juntendo University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-27
• Last Update Posted: 22 January 2024
• Study Completion: 2025-10-18

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified