Clinical trial · Observational
A Metabolomic Study of Polycystic Ovary Syndrome With Insulin Resistance and Its Relationship With TCM Syndrome Types
Fujian Maternity and Child Health Hospital
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| all the indicators | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- obese with PCOS
- description
- all the indicators
- interventionNames
- Other: all the indicators
- label
- nonobese with PCOS
- description
- all the indicators
- interventionNames
- Other: all the indicators
- label
- PCOS with IGT
- description
- all the indicators
- interventionNames
- Other: all the indicators
- label
- PCOS with T2DM
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. The diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam consensus criteria recommended by European Society of Human Reproduction and Embryology and American Society for Reproductive Medicine in 2003(2 out of 3):Oligo-and/or anovulation;Clinical and/or biochemical signs of hyperandrogenism;Polycystic ovaries. 2. Diagnostic criteria for insulin resistance: use the HOMA model to evaluate insulin resistance. The HOMA index of insulin resistance (HOMA-IR) = (fasting blood glucose (mmol/L)× fasting insulin (mIU/L) /22.5. 3. voluntary subjects Exclusion Criteria: 1. the exclusion of other causes of Kaohsiung hormones, such as congenital adrenal hyperplasia, Cushing syndrome, androgen secreting tumors, and other diseases caused by ovulation disorders, such as hyperprolactinemia, premature ovarian failure, pituitary or hypothalamus closed by etc; 2. exclusion of organic disease or other endocrine diseases; 3. with liver and kidney, cerebral blood vessels, cardiovascular and hematopoietic disorders, such as primary disease, mental patients; 4. patients who had been treated with steroids in nearly three months , such as the birth control pill, and corticosteroids.
References
Publications (14)
- RESULTSuvarna Y, Maity N, Kalra P, Shivamurthy MC. Comparison of efficacy of metformin and oral contraceptive combination of ethinyl estradiol and drospirenone in polycystic ovary syndrome. J Turk Ger Gynecol Assoc. 2016 Jan 12;17(1):6-9. doi: 10.5152/jtgga.2016.16129. eCollection 2016. PMID 27026772
- RESULTVictor VM, Rovira-Llopis S, Banuls C, Diaz-Morales N, Martinez de Maranon A, Rios-Navarro C, Alvarez A, Gomez M, Rocha M, Hernandez-Mijares A. Insulin Resistance in PCOS Patients Enhances Oxidative Stress and Leukocyte Adhesion: Role of Myeloperoxidase. PLoS One. 2016 Mar 23;11(3):e0151960. doi: 10.1371/journal.pone.0151960. eCollection 2016. PMID 27007571
- RESULTSathyapalan T, Atkin SL. Recent advances in cardiovascular aspects of polycystic ovary syndrome. Eur J Endocrinol. 2012 Apr;166(4):575-83. doi: 10.1530/EJE-11-0755. Epub 2011 Nov 17. PMID 22096112
- RESULTChen L, Xu WM, Zhang D. Association of abdominal obesity, insulin resistance, and oxidative stress in adipose tissue in women with polycystic ovary syndrome. Fertil Steril. 2014 Oct;102(4):1167-1174.e4. doi: 10.1016/j.fertnstert.2014.06.027. Epub 2014 Jul 23. PMID 25064406
- RESULTWehr E, Gruber HJ, Giuliani A, Moller R, Pieber TR, Obermayer-Pietsch B. The lipid accumulation product is associated with impaired glucose tolerance in PCOS women. J Clin Endocrinol Metab. 2011 Jun;96(6):E986-90. doi: 10.1210/jc.2011-0031. Epub 2011 Apr 6. PMID 21470992
- RESULTZhao Y, Fu L, Li R, Wang LN, Yang Y, Liu NN, Zhang CM, Wang Y, Liu P, Tu BB, Zhang X, Qiao J. Metabolic profiles characterizing different phenotypes of polycystic ovary syndrome: plasma metabolomics analysis. BMC Med. 2012 Nov 30;10:153. doi: 10.1186/1741-7015-10-153. PMID 23198915
- RESULTCollins FS, Green ED, Guttmacher AE, Guyer MS; US National Human Genome Research Institute. A vision for the future of genomics research. Nature. 2003 Apr 24;422(6934):835-47. doi: 10.1038/nature01626. Epub 2003 Apr 14. No abstract available.