A Metabolomic Study of Polycystic Ovary Syndrome With Insulin Resistance and Its Relationship With TCM Syndrome Types

NCT02992093 | Unknown DMC

• 1 other identifier: Dunjingjing
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

PCOS

Keywords

Polycystic ovary syndrome; Metabonomics; Traditional Chinese medicine syndromes

Outcome Measures

Primary Outcomes (1)

• metabolites

  Collect serum from all the subjects , through the sample pretreatment method,the metabolic features are first scanned by using Liquid Chromatography-Mass Spectrometry coupled w ith Mass Spectrometry,extracted ion-pairs were fetched to type RRLC and QTRAP(MS/MS) for multiple reaction monitoring（MRM） detection,Peak detection and alignment from the raw date use Analyst Quantitation software ,use SIMCA-P11.0 to conduct principle component analysis(PCA) and partial least squares-discriminant analysis(PLS-DA) model,use SPSS18.0 software package for statistical analysis

  six months

Secondary Outcomes (16)

• BMI

  day 1

• WHR

  day 1

• FSH

  day 2 to 5 in menstrual period

• LH

  day 2 to 5 in menstrual period

• PRL

  day 2 to 5 in menstrual period

Study Arms (5)

obese with PCOS

all the indicators

Other: all the indicators

nonobese with PCOS

all the indicators

Other: all the indicators

PCOS with IGT

all the indicators

Other: all the indicators

PCOS with T2DM

all the indicators

Other: all the indicators

Healthy volunteers

all the indicators

Other: all the indicators

Interventions

all the indicators OTHER

BMI、WHR、FSH、LH、PRL、T、E2、TG、CHOL、LDL-C、HDL-C、FBG、OGTT、FINS、insulin release test、HOMA index、identification of metabolites

Healthy volunteers; PCOS with IGT; PCOS with T2DM; nonobese with PCOS; obese with PCOS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The selection of research subjects: PCOS non obese patients, PCOS obese patients,PCOS with IGT patients,PCOS with T2DM patients,and body mass index matched healthy volunteers collect from Fujian Maternity and Child Health Hosptial

You may qualify if:

• 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.
• 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.
• voluntary subjects

You may not qualify if:

• with liver and kidney, cerebral blood vessels, cardiovascular and hematopoietic disorders, such as primary disease, mental patients；
• patients who had been treated with steroids in nearly three months , such as the birth control pill, and corticosteroids.

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (1)

Fujian Maternity and Child Health Hosptial

Fuzhou, Fujian, 350000, China

Location

Related Publications (14)

• Suvarna 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 RESULT

• Victor 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 RESULT

• Sathyapalan 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 RESULT

• Chen 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 RESULT

• Wehr 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 RESULT

• Zhao 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 RESULT

• Collins 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.

  PMID: 12695777 RESULT

• Azziz R, Carmina E, Dewailly D, Diamanti-Kandarakis E, Escobar-Morreale HF, Futterweit W, Janssen OE, Legro RS, Norman RJ, Taylor AE, Witchel SF; Task Force on the Phenotype of the Polycystic Ovary Syndrome of The Androgen Excess and PCOS Society. The Androgen Excess and PCOS Society criteria for the polycystic ovary syndrome: the complete task force report. Fertil Steril. 2009 Feb;91(2):456-88. doi: 10.1016/j.fertnstert.2008.06.035. Epub 2008 Oct 23.

  PMID: 18950759 RESULT

• Sun L, Hu W, Liu Q, Hao Q, Sun B, Zhang Q, Mao S, Qiao J, Yan X. Metabonomics reveals plasma metabolic changes and inflammatory marker in polycystic ovary syndrome patients. J Proteome Res. 2012 May 4;11(5):2937-46. doi: 10.1021/pr3000317. Epub 2012 Apr 13.

  PMID: 22428626 RESULT

• Atiomo W, Daykin CA. Metabolomic biomarkers in women with polycystic ovary syndrome: a pilot study. Mol Hum Reprod. 2012 Nov;18(11):546-53. doi: 10.1093/molehr/gas029. Epub 2012 Jul 18.

  PMID: 22809877 RESULT

• Escobar-Morreale HF, Samino S, Insenser M, Vinaixa M, Luque-Ramirez M, Lasuncion MA, Correig X. Metabolic heterogeneity in polycystic ovary syndrome is determined by obesity: plasma metabolomic approach using GC-MS. Clin Chem. 2012 Jun;58(6):999-1009. doi: 10.1373/clinchem.2011.176396. Epub 2012 Mar 16.

  PMID: 22427353 RESULT

• Zhao X, Xu F, Qi B, Hao S, Li Y, Li Y, Zou L, Lu C, Xu G, Hou L. Serum metabolomics study of polycystic ovary syndrome based on liquid chromatography-mass spectrometry. J Proteome Res. 2014 Feb 7;13(2):1101-11. doi: 10.1021/pr401130w. Epub 2014 Jan 24.

  PMID: 24428203 RESULT

• Wild RA, Rizzo M, Clifton S, Carmina E. Lipid levels in polycystic ovary syndrome: systematic review and meta-analysis. Fertil Steril. 2011 Mar 1;95(3):1073-9.e1-11. doi: 10.1016/j.fertnstert.2010.12.027. Epub 2011 Jan 17.

  PMID: 21247558 RESULT

• Gaster M, Nehlin JO, Minet AD. Impaired TCA cycle flux in mitochondria in skeletal muscle from type 2 diabetic subjects: marker or maker of the diabetic phenotype? Arch Physiol Biochem. 2012 Jul;118(3):156-89. doi: 10.3109/13813455.2012.656653. Epub 2012 Mar 5.

  PMID: 22385297 RESULT

Related Links

• Detection of urine metabolites in polycystic ovary syndrome by UPLC triple-TOF-MS
• Metabonomic analysis and biomarker screening of serum for polycystic ovary syndrome patients with phlegm-dampness syndrome

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Jinbang Xu

  Fujian Maternity and Child Health Hosptial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinbang Xu

CONTACT

13559958096; 13559958096@126.com

Jingjing Dun

CONTACT

18520124299; 409381572@qq.com

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 14, 2016
• Study Start: December 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 15, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)