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The type-2 diabetes mellitus(T2DM), metabolic syndrome, cardiovascular disease complications induced by polycystic ovary syndrome(PCOS) with insulin resistance(IR), which become serious threat to public health. In this observational study, obese patients with PCOS,nonobese patients with PCOS, PCOS patients with impaired glucose tolerance(IGT), PCOS patients with type-2 diabetes mellitus(T2DM), and healthy volunteers would enrolled into this study, through the Liquid Chromatography-Mass Spectrometry coupled to Mass Spectrometry( LC-MS/MS)and Rapid Resolution Liquid Chromatography(RRLC) and Quadrupole Linear Trap(QTRAP)Mass Spectrometry coupled to Mass Spectrometry (MS/MS)analysis of serum samples collected from PCOS patients and healthy volunteers to screen the biomarker of diagnosis for PCOS with insulin resistance, to explore the correlation between traditional chinese medicine (TCM) syndrome(phlegm, kidney yin deficiency, kidney yang deficiency, qi stagnation and blood stasis,dampness-heat of liver channel)and metabolites of PCOS.
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(2)Endocrine hormones: collect serum from all the subjects,use the enzyme linked immunosorbent assay (ELISA) method to detect the level of serum follicle-stimulating hormone(FSH),luteinizing hormone(LH),prolactin(PRL),estradiol(E2),testosterone(T). Blood lipid: glycerin three vinegar (TG), cholesterol (CHOL) detect by enzymatic method, low density lipoprotein (LDL-C), high density lipoprotein (HDL-C) detect by the turbidity method. Glucose tolerance and insulin release test after glucose loading: all subjects were fasting for 8 to 10 h, check the fasting blood glucose(FBG)and fasting insulin (FINS).The oral glucose tolerance test(OGTT)and insulin release test were performed in the next morning.
5.Study on the characteristics of metabolism
(1)Through the sample pretreatment method, analyzes the optimization of the condition of mass spectrometry, according to the requirements of the metabolism to establish the blood sample LC-MS/MS metabolism analysis method.(2)Carry out the analysis of metabolism and data collection.(3)Model building and data analysis(4)Use RRLC and QTRAP type MS/MS with positive and negative ion detection mode with the combination of hyphenated techniques, combined with the method of data statistics,to establish multiple reaction monitoring(MRM) detection, to verify the precision and sensitivity of the method.
6.Statistical methods: All data use statistical product and service solutions18.0(SPSS18.0)software package for statistical analysis. According to the character of clinical trial data (measurement, classification and grade data), select the appropriate statistical analysis method.receiver operating characteristic curve(ROC) analysis of the potential metabolites selected from the targeting metabolic biomarker.
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300 participants in 5 patient groups
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Central trial contact
Jinbang Xu; Jingjing Dun
Data sourced from clinicaltrials.gov
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