The effects of chiglitazar and metformin on insulin resistance in women with a normal BMI and polycystic ovary syndrome: a randomized controlled study.
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BACKGROUND: Polycystic ovary syndrome (PCOS) affects both obese and normal-weight women, with limited treatment options available for the nonobese population. Metformin (MET), an insulin sensitizer, is used to ameliorate insulin resistance and associated reproductive endocrine metabolic dysfunctions in PCOS patients. The efficacy of chiglitazar, a peroxisome proliferator-activated receptor (PPAR) pan-agonist used for type 2 diabetes treatment, is undefined in PCOS patients. In this randomized controlled trial, the effects of metformin versus chiglitazar on insulin resistance and reproductive endocrine metabolism are assessed in normal-weight women with PCOS. METHODS: Fifty-five normal-weight women with PCOS aged 18 to 45 years were included. Patients were randomly assigned to receive either chiglitazar (32 mg once daily) or MET (500 mg twice daily). Anthropometric measurements, menstrual cycle changes, sex hormone characteristics, and an oral glucose-insulin release test (OGIRT) were performed after three months of continuous use. RESULTS: Following 12 weeks of treatment with chiglitazar, there were notable improvements in insulin and blood glucose levels at the 120-minute mark of the OGIRT, and the peak insulin levels were significantly earlier than those at baseline, indicating a more pronounced effect than that in the MET group. Moreover, both the chiglitazar and MET treatments led to significant improvements in menstrual cyclicity, and luteinizing hormone (LH) and testosterone (Testo) levels, with no significant differences detected between the two groups. Prolactin (PRL) levels were significantly elevated in the Chiglitazar group compared with the MET group. There was also no significant difference in the efficacy of the two treatments for PCOS in subgroups with different baseline IR0 values. CONCLUSION: In normal-weight PCOS patients, chiglitazar is similar to MET with regard to improving menstrual frequency and total testosterone (TT) and LH levels. Compared with MET, chiglitazar significantly improves fasting insulin levels, insulin and blood glucose levels at 120 min of the OGIRT and advances the insulin peak. TRIAL REGISTRATION: This single-center, open-label, 1:1 randomized controlled trial is registered with ClinicalTrials (NCT06125587, ClinicalTrials.gov) on 2023-11-05.