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

December 14, 2016 updated by: Fujian Maternity and Child Health Hospital

Fujian Maternity and Child Health Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. The selection of research subjects: All the subjects collect from Fujian Maternity and Child Health Hospital.
  2. The participants will be divided into five groups：obese with PCOS，nonobese with PCOS，PCOS with IGT，PCOS with T2DM，healthy volunteers.the syndrome type of PCOS will be divided into five types: phlegm, kidney yin deficiency, kidney yang deficiency, liver qi stagnation and blood stasis syndrome, dampness-heat of liver channel.
  3. Ethical requirements and subjects' informed consent Before clinical trials begin, the program needs to be approved by the ethics committee to approve and sign the approval.The subjects need fully aware of the clinical trial and are given sufficient time to consider whether they are willing to participate in the trial, and to sign the informed consent form.
  4. Indicator test (the cost of all health volunteers are paid by the research) (1)Physical examination: blood pressure, height, body weight,waist circumference,hip circumference，body mass index(BMI),waist-hip ratio（WHR）.

(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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Fujian Maternity and Child Health Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
obese with PCOS
all the indicators
Other: all the indicators
BMI、WHR、FSH、LH、PRL、T、E2、TG、CHOL、LDL-C、HDL-C、FBG、OGTT、FINS、insulin release test、HOMA index、identification of metabolites
nonobese with PCOS
all the indicators
Other: all the indicators
BMI、WHR、FSH、LH、PRL、T、E2、TG、CHOL、LDL-C、HDL-C、FBG、OGTT、FINS、insulin release test、HOMA index、identification of metabolites
PCOS with IGT
all the indicators
Other: all the indicators
BMI、WHR、FSH、LH、PRL、T、E2、TG、CHOL、LDL-C、HDL-C、FBG、OGTT、FINS、insulin release test、HOMA index、identification of metabolites
PCOS with T2DM
all the indicators
Other: all the indicators
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
all the indicators
Other: all the indicators
BMI、WHR、FSH、LH、PRL、T、E2、TG、CHOL、LDL-C、HDL-C、FBG、OGTT、FINS、insulin release test、HOMA index、identification of metabolites

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metabolites
Time Frame: six months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI
Time Frame: day 1
weight（kg）/ the square of height(m2)
day 1
WHR
Time Frame: day 1
day 1
FSH
Time Frame: day 2 to 5 in menstrual period
use the ELISA method to detect the levels of serum FSH
day 2 to 5 in menstrual period
LH
Time Frame: day 2 to 5 in menstrual period
use the ELISA method to detect the levels of serum LH
day 2 to 5 in menstrual period
PRL
Time Frame: day 2 to 5 in menstrual period
use the ELISA method to detect the levels of serum PRL
day 2 to 5 in menstrual period
T
Time Frame: day 2 to 5 in menstrual period
use the ELISA method to detect the levels of serum T
day 2 to 5 in menstrual period
E2
Time Frame: day 2 to 5 in menstrual period
use the ELISA method to detect the levels of serum E2
day 2 to 5 in menstrual period
TG
Time Frame: day 1
use the enzymatic method to detect the levels of serum TG
day 1
CHOL
Time Frame: day 1
use the enzymatic method to detect the levels of serum CHOL
day 1
LDL-C
Time Frame: day 1
use turbidity method to detect the levels of serum LDL-C
day 1
HDL-C
Time Frame: day 1
use turbidity method to detect the levels of serum HDL-C
day 1
FBG
Time Frame: day 1
use glucose oxidase method to detect the levels of serum FBG
day 1
OGTT
Time Frame: day 1
The levels of blood glucose about 1, 2, 3 hours after glucose loading
day 1
FINS
Time Frame: day 1
use radioimmunoassay to detect the levels of serum FINS
day 1
insulin release test
Time Frame: day 1
The levels of Insulin about 1, 2, 3 hours after glucose loading
day 1
HOMA index
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Maternity and Child Health Hospital

Investigators

  • Principal Investigator: Jinbang Xu, Fujian Maternity and Child Health Hosptial

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

December 1, 2016

First Submitted That Met QC Criteria

December 11, 2016

First Posted (Estimate)

December 14, 2016

Study Record Updates

Last Update Posted (Estimate)

December 15, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dunjingjing

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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