Effect of Dapagliflozin versus standard care on risk of recurrence of kidney stones measured by urinary super-saturation: A Randomised placebo controlled study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Change in urinary super saturation in the study groups, urinary markers of inflammation and incidence of new stone formation
Overview
Brief Summary
Nephrolithiasis is a common renal disease that frequently recurs and amounts to large disease burden in Indian patients with no effective evidence based preventive medication. A huge number of patients have to undergo different types of surgeries for stone clearance. Despite of getting cleared stone almost 50 percent patients land up with re-stone formation in next 10 years. Patients with multiple stones and / or abnormal urinary super-saturation have high risk of repeated stone formation. Surgical interventions are associated with morbidity, prolonged hospital stay, sepsis or death in few cases. If not managed timely may lead to renal failure. There is no definitive means to prevent or delay the recurrence of stone disease in urinary tract. Sodium-glucose cotransporter-2 (SGLT2, encoded by SLC5A2) inhibitors, a novel class of antidiabetic agents, induce urinary glucose excretion by inhibiting SGLT2 at the S1 and S2 segments of the proximal tubules. Apart from glycaemic control, SGLT2 inhibitors have diverse functions, including blood pressure reduction improved cardiovascular outcomes, renoprotection, lipid improvement, and weight, visceral fat, and serum uric acid level reduction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with known renal stone disease, after getting stone clearance by either medical expulsive therapy or by endoscopic surgery, Age between 18 to 60 years, Renal stones of the following types: Calcium phosphate, Calcium Oxalate, Uric acid.
Exclusion Criteria
- •Recurrent stone formers with confirmed alternate diagnoses such as incomplete RTA, Bartter’s, cystinuria, history of surgery in prior 6 weeks, Dehydration, Hemodynamic instability, Critical illness, Lower urinary tract symptoms, Severe renal failure with eGFR less than 45 ml per min, Patient on any SGLT2 inhibitors at the time of enrolment or in previous 3 months, Patient on teriparatide, bisphosphonates, denosumab at the time of enrolment or in previous 6 months, Sepsis or septic shock, Moribund patients with reduced life expectancy, Severe cardiopulmonary disease, Pregnancy and lactation, History of genital infections or urinary tract infections, Primary Hyperparathyroidism, Malignancy, Congenital anomaly of kidney and urinary tract.
Outcomes
Primary Outcomes
Change in urinary super saturation in the study groups, urinary markers of inflammation and incidence of new stone formation
Time Frame: Baseline and 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Vipin Chandra
All india institute of Medical sciences, patna