PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries Clinical Trial
Official title:
Study on the Efficacy and Safety of Chiglitazar Sodium in the Treatment of Polycystic Ovary Syndrome With Type 2 Diabetes
| Verified date | February 2023 |
| Source | Affiliated Hospital of Nantong University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 142 |
| Est. completion date | September 30, 2024 |
| Est. primary completion date | September 30, 2023 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | N/A to 40 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Gu Yunjuan | Nantong | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| Affiliated Hospital of Nantong University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of plasma glucose | Assessment the change level of plasma glucose. The unit is mmol/L. | 12 weeks | |
| Primary | The recovery of menstrual cycle | Assessment the recovery of menstrual cycle. The unit is day. | 12 weeks | |
| Secondary | The changes in body weight | Assessment the changes of body weight. The unit is kilogram. | 12 weeks |