The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
165
Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.
Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Improvement in insulin resistance over 12 weeks
Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)
Time frame: Baseline and 12 weeks
Improvement in serum androgen level over 12 weeks
Change in androgen level assessed by free testosterone index(FAI)
Time frame: Baseline and 12 weeks
Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)
Time frame: Baseline to 12 week
Change in serum free testosterone(FT)
Time frame: Baseline to 12 week
Change in serum sex hormone binding globulin(SHBG)
Time frame: Baseline to 12 week
Net change in total testosterone (TT) level
Time frame: Baseline and 12 weeks
Net change in dehydroepiandrosterone-sulfate(DHEAS) level
Time frame: Baseline and 12 weeks
Net change in androstenedione(AD) level
Time frame: Baseline and 12 weeks
Net change in luteinzing hormone(LH) level
Time frame: Baseline and 12 weeks
Net change in waist circumference
Time frame: Baseline to 12 week
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Net Change in liver fat
Liver fat will be assessed by liver fibroscan.
Time frame: Baseline to 12 week
Change in ovulation rate assessed by serum progesterone
Time frame: Baseline to 12 week
Net change in body weight
Time frame: Baseline to 12 week
Net change in BMI
Time frame: Baseline to 12 week
Net change in glucose
Time frame: Baseline to 12 week