Type 2 Diabetes Mellitus Clinical Trial
Official title:
SGLT-2 Inhibition and Cardiovascular Disease. Metabolomics Study of Potential Factors Involved in Cardio- and Nephroprotection
This study evaluates the metabolomics changes associated with dapagliflozin treatment in patients with type 2 diabetes mellitus (T2DM). The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo once daily for 12 weeks.
In this study, we hypothesize that metabolomics changes that occur in patients with T2DM
after initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors) treatment may be
responsible for the beneficial cardiovascular and kidney effects observed in clinical trials
with SGLT2i. Also, we propose that the study of the specific metabolome associated with the
treatment with SGLT2i could help identify the possible metabolites and molecules that reduce
CVD (cardiovascular disease) and renal disease in patients with T2DM.
The participants in the study will be randomized to receive 10 mg dapagliflozin or placebo
once daily of for 12 weeks. Besides, all participants will be advised to engage in 150 min or
more of moderate-to vigorous intensity physical activity per week, spread over at least 3
days/week, with no more than 2 consecutive days without activity and to engage in 2-3
sessions/week of resistance exercise on nonconsecutive days. Moreover, these patients will be
advised to follow a lifestyle program that achieve a 500-750 kcal/day energy deficit or
provide≈1,200-1,500 kcal/day for women and 1,500-1,800 kcal/day for men, adjusted for the
individual's baseline body weight.
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