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The GranStone Trial
Sponsor: Martin Blomberg Jensen
Summary
This study will investigate whether treatment with empagliflozin or losartan can reduce the risk of kidney stone formation in patients with paraffin disease, a condition caused by the injection of paraffin oil into muscle tissue for cosmetic muscle enlargement. Paraffin disease can lead to chronic inflammation, disturbances in calcium regulation, high blood calcium levels, kidney stones, and impaired kidney function. Previous studies from Herlev-Gentofte Hospital have shown that kidney stones occur in nearly half of affected patients, while approximately one-third develop reduced kidney function. Current treatment primarily consists of high-dose corticosteroids, which can reduce blood calcium levels but cause substantial adverse effects and may not adequately control the underlying disease process. Both empagliflozin and losartan are widely used medications with documented kidney-protective effects in other chronic kidney diseases. This randomized clinical trial will evaluate whether either treatment can prevent kidney stone formation and slow kidney-related complications in patients with paraffin disease. The purpose of this study is to determine whether treatment with empagliflozin or losartan can prevent kidney stone formation and improve kidney health in patients with paraffin disease.
Official title: Prevention of Kidney Stones Due to Paraffin Oil Induced Granuloma: A Prospective Interventional Study
Key Details
Gender
MALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-09
Completion Date
2029-04
Last Updated
2026-09-18
Healthy Volunteers
No
Conditions
Interventions
empagliflozin (Jardiance) 25 mg
Once daily 25 mg tablet PO
Losartan 100 mg
Once daily 100 mg tablet PO
Locations (1)
Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev, Herlev
Herlev, Denmark