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Table 1 Inclusion and exclusion criteria

From: Efficacy of the treatment with dapagliflozin and metformin compared to metformin monotherapy for weight loss in patients with class III obesity: a randomized controlled trial

Inclusion criteria

Exclusion criteria

Withdrawal criteria

Age between 18 and 60 years

Current use of insulin or SU

Becoming pregnant during the study

BMI ≥ 40 kg/m2

Chronic kidney failure with eGFR ≤ 60 ml/min/1.73 m2

Tobacco use (in the last month) (for the secondary objectives)

HbA1c < 9%

Use of loop diuretics

Use of steroids drugs during the study (for the secondary objectives)

Patients willing to participate and that sign the informed consent letter

Concomitant illnesses that predispose to volume depletion, weight loss (including oncological diseases), or metabolic acidosis (including drug users)

 

Candidates to bariatric surgery

History of recurrent genital or urinary tract infections

Current treatment with medications/products for weight control

Untreated or uncontrolled hypothyroidism (defined through TSH higher than 4.2 μU/ml)

Pregnant or lactating mother

Tobacco use (in the last month)

Current use of steroids or nonsteroidal anti-inflammatory drugs

  1. BMI body mass index, HbA1c glycated hemoglobin, SU sulfonylureas, eGFR estimated glomerular filtration rate, TSH thyroid stimulating hormone, CTCAE Common Terminology Criteria for Adverse Effects