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Purpose and significance: To explore the clinical efficacy and safety of Chiglitazar sodium in polycystic ovary syndrome with type 2 diabetes
Methods: From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.
Type of study: randomized controlled, prospective, intervention study.
Full description
From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators.
Enrollment
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Inclusion criteria
Clinical diagnosis of Type 2 diabetes mellitus Clinical diagnosis of Polycystic ovarian syndrome Must be able to swallow tablets
Exclusion criteria
Mental diseases, autoimmune diseases, hematological diseases, malignant tumors, other ovarian diseases (such as ovarian cysts), sexually transmitted diseases Infertility caused by gynecological diseases such as uterine cat's eye disease and other reasons Abnormal function of important organs Congenital adrenocorticosis, hypothyroidism, Cushing's syndrome and other endocrine diseases Patients who have recently prepared or become pregnant
Primary purpose
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Interventional model
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142 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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