It is currently indicated in the management of patients with type 2 diabetes (T2D) because of its sustained effect on the reduction of glycemia and glycated hemoglobin (HbA1c). Retrospectively registered on May 29, 2019.ĭapagliflozin is a selective sodium-glucose cotransporter type 2 inhibitor (iSGLT2) that blocks glucose resorption in the proximal tubule of the kidney, thereby increasing urinary glucose excretion and reducing blood glucose levels. This effect could be translated into less time before undergoing bariatric surgery and better control of associated comorbidities. The use of dapagliflozin in this population could improve weight loss and other cardiovascular factors. Discussionįorty-six percent of the patients in our Obesity Clinic have been diagnosed with prediabetes (32%) or diabetes (14%). An intention-to-treat analysis will be used. A serum sample to determine glucagon, ghrelin, adiponectin, resistin, interleukin 6, and interleukin 10 will be collected at baseline and before surgery, or at 12 months (whatever happens first).Īdherence to treatment and adverse and secondary events will be recorded throughout the study. Anthropometric and biochemical variables will be recorded at baseline and at 1, 3, 6, and 12 months. A run-in period of one month will be used to assess tolerance and adherence to treatment regimens. All participants will receive personalized nutritional advice during the study. The sample size required is 108 patients, which allows for a 20% dropout rate: 54 patients in the metformin group and 54 in the metformin/dapagliflozin group. Subjects will be randomized to one of two groups as follows: 1) metformin tablets 850 mg PO bid or 2) metformin tablets 850 mg PO bid plus dapagliflozin tablets 10 mg PO qd. This randomized phase IV clinical trial will include patients with diabetes or prediabetes who are between the ages of 18 and 60 years and exhibit grade III obesity (defined as body mass index ≥ 40 kg/m 2). We also aimed to assess the effect of this combined treatment on waist circumference, triglycerides, blood pressure, and inflammatory cytokines. The primary outcome of the study is to determine if the combined treatment with dapagliflozin and metformin is more effective than monotherapy with metformin for weight loss in patients with class III obesity and prediabetes or diabetes who are awaiting bariatric surgery (including those patients who do have surgery). Therapy with dapagliflozin is associated with a mild but sustained weight loss in patients with diabetes. Beyond its effects on glucose, metformin has been suggested by some studies to result in weight loss. ![]() Metformin and dapagliflozin are two drugs approved for the treatment of diabetes. New pharmacological strategies that focus on people with class III obesity are required. Mexico has one of the highest prevalence rates of obesity worldwide.
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