SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial

Summary

SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors \[SGLT2i\] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate \[SU\] levels of gout patients, as well as levels of highly-sensitivity C-reactive protein \[hsCRP\] and interleukin 6 \[IL-6\], and estimate gout flares over 3 months, in order to develop a full-scale RCT of clinical endpoints to directly inform gout care guidelines.

Eligibility

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Provision of signed and dated informed consent form.
2. Fulfilling American College of Rheumatology \[ACR\]/European Alliance of Associations for Rheumatology \[EULAR\] gout criteria
3. 1+ gout flares in last 12 months
4. Serum urate level ≥ 6mg/dl
5. Males and females; Age 18-80
6. Willingness to adhere to the study intervention procedures.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Estimated Glomerular Filtration Rate \[eGFR\] \<20ml/min
2. Colchicine or nonsteroidal anti-inflammatory drug \[NSAID\] prophylaxis
3. active cardiovascular disease \[CVD\], type-1 diabetes
4. pregnant and lactating women
5. Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. \[History of ketoacidosis, end-stage or decompensated liver disease, active cancer\]
6. Use of anti-obesity drugs
7. Basal-bolus or multiple daily injection insulin regimens, or loop diuretics

Conditions2

Interventions1

Locations1 site

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