Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls

An observational study of Polycystic Ovary Syndrome, run by Zhang Manna at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder in reproductive-aged women， which associated with increased risks to develop metabolic disorders, including cardiovascular diseases, diabetes mellitus, and cerebrovascular diseases. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Polycystic Ovary Syndrome
How many people: 121 participants
Where: 1 siteChina
Study dates: 1 May 2019to 31 Dec 2022
How long will I take part?: 3 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Study population: This study enrolled 63 PCOS women with obesity and 58 age- and body mass index (BMI)-matched subjects with normal menstrual cycles who were admitted to the Department of Endocrinology, Shanghai Tenth People's Hospital, between April 2019 and November 2022.

Who may be able to join

patients with obesity (BMI>28kg/m2)
aged 18-45 years
Diagnosis of PCOS
the Rotterdam diagnosis criteria (2003)

Who cannot join

Pregnant women;
Hyperthyroidism or hypothyroidism
Severe liver and kidney function injury
Cancer patients;
Associated with severe infection, severe anemia, neutropenia and other blood system diseases;
Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;

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Patients with mental illness or intellectual disability;
Have taken drugs for PCOS treatment in the last three months;
Taking drugs or foods (antibiotics, probiotics, yogurt, etc.) that affect the intestinal flora for nearly one month;
Have a long history of taking hormone therapy;
Currently or recently participating in another clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Endocrinology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200070

Other trials in China

About this study

Read the detailed description

To study the pathogenesis of diseases, the study of multi-omics approach has been applied in various diseases researching . Obesity and PCOS are both metabolic disorders, and both have an impact on metagenomics, metabolomics and transcriptome. Currently, multi-omics studies based on obese PCOS are still limited. Therefore, this study tried to use a multi-omics approach that integrates the gut microbiome, serum metabolomics, serum transcriptomics, and clinical indicators to distinguish obese PCOS from obese non-PCOS women. To investigate whether the specific composition of the gut microbiome is associated with PCOS in obese women. Serum metabolomics and transcriptomics were analyzed to explore potential metabolic pathways. Meanwhile, gut microbiome and serum metabolomics are used to predict the occurrence of PCOS. Then, a new metabolite that could predict PCOS were tested on female mice with high fat diet (HFD).

Conditions: Polycystic Ovary Syndrome
Being tested: No intervention
Keywords: Gut microbiome, metabolomics, transcriptomic, obesity
Medical subject headings: Polycystic Ovary Syndrome, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
No intervention

Study groups in NCT05468476
Study group	Role	What they receive
Women with PCOS (PCOS group)		PCOS women with obesity previously diagnosed with PCOS（meet the 2003 Rotterdam diagnostic criteria） not using hormonal therapy and without other significant health or endocrine issues. Receives: Other: No intervention
Women without PCOS (Non-PCOS group)		This study enrolled age- and body mass index (BMI)-matched subjects with normal menstrual cycles, not using hormonal therapy, and without any significant health or endocrine issues. Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Phenotype differences in the Serum non-targeted metabolomics by LC-MS.
Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze non-target metabolites.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Phenotype differences in the gut microbiome by metagenomic sequencing.
Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.
Measured: Samples to be collected once per participant within 7 days of enrollment
Phenotype differences in the transcriptome expression by mRNA-seq.
Understand phenotypical differences from biological samples comparing women with and without PCOS. The researcher will collect and analyze Venipuncture blood for RNA. Differences in the expression of genes between the two groups of subjects, analysis to select possible pathogenic factors leading to the pathogenesis of PCOS.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Phenotype differences in the Serum targeted metabolomics by LC-MS.
Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze the target metabolite.
Measured: Samples to be collected once per participant within 7 days of enrollment.

Secondary outcomes (37)

BMI
Body mass index (BMI)=weight(kg)/height(m)^2.
Measured: Samples to be collected once per participant within 7 days of enrollment.
TT
total testosterone in nmol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
LH
luteinizing hormone in IU/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
FSH
The follicle-stimulating hormone in IU/l.
Measured: Samples to be collected once per participant within 7 days of enrollment.
E2
Estradiol in pmol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
PRL
Prolactin in uIU/ml.
Measured: Samples to be collected once per participant within 7 days of enrollment.
HC
Hip Circumference in centimeters.
Measured: Samples to be collected once per participant within 7 days of enrollment.
WC
Waist Circumference in centimeters.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Waist/hip Ratio
WHR=(Waist Circumference in centimeters)/(Hip Circumference in centimeters).
Measured: Samples to be collected once per participant within 7 days of enrollment.
Menstrual cycles
the total number of menstrual periods in the last year.
Measured: Samples to be collected once per participant within 7 days of enrollment.
FBG
fasting blood-glucose in mmol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
PBG
postprandial blood-glucose in mmol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
FINS
fasting serum insulin in mU/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
PINS
postprandial insulin in mU/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
ALT
alanine aminotransferase in U/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
AST
aspartate aminotransferase in U/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
UA
Uric acid in umol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
CR
Creatinine in umol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Ferriman-Gallwey score
The minimum value of Ferriman-Gallwey score is 0 and the maximum value is 44. An Ferriman-Gallwey score greater than or equal to 6 is considered to be a clinical manifestation of androgen excess.
Measured: Samples to be collected once per participant within 7 days of enrollment.
HOMA-IR
Homeostatic model assessment insulin resistance index=FBG*FINS/22.5.
Measured: Samples to be collected once per participant within 7 days of enrollment.
HbA1c (%)
glycosylated hemoglobin (%).
Measured: Samples to be collected once per participant within 7 days of enrollment.
γ-GT
γ-glutamyl transferase in U/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
BUN
urea nitrogen in mmol/L.
Measured: Samples to be collected once per participant within 7 days of enrollment.
SOD
Superoxide dismutase in pg/ml.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Interleukin 22, IL-22
Interleukin 22 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
Measured: Samples to be collected once per participant within 7 days of enrollment.
Interleukin 6，IL-6
Interleukin 6 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
Interleukin 8， IL-8
Interleukin 8 in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
Tumor Necrosis Factor， TNF
Tumor Necrosis Factor in pg/ml. The factor reflects that the organism is in an inflammatory state. There is no maximum or minimum value for the factor and the higher scores mean a worse outcome.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
FT
free testosterone in nmol/L.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
DHEAS
Dehydroepiandrosterone Sulfate in ug/dl.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
SHBG
sex hormone-binding globulin in nmol/L.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
AD
Androstenedione in ng/ml.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
LDL-c
low-density lipoprotein cholesterol in mmol/L.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
HDL-c
high-density lipoprotein cholesterol in mmol/L.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
TC
Total Cholesterol in mmol/L.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
TG
Triglyceride in mmol/L.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.
CRP
C reactive protein in pg/ml.
Measured: Blood samples to be collected once per participant within 7 days of enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201931 Dec 2022

First posted21 Jul 2022
Study start1 May 2019
Primary completion31 Aug 2022
Study completion31 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 121 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT05468476
Sponsor's protocol ID: Multi-omics PCOS
Status last verified: Apr 2023
First submitted: 18 May 2022
Last updated: 1 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

All Polycystic Ovary Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-omics Analysis of Women With PCOS and Obesity Compared With Non-PCOS Obese Controls
ClinicalTrials.gov ID: NCT05468476
Acronym / sponsor ID: Multi-omics PCOS
Conditions: Polycystic Ovary Syndrome
Keywords: Gut microbiome, metabolomics, transcriptomic, obesity
Study type: Observational
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: Zhang MannaUniversity, hospital or other
Study start: 1 May 2019 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 21 Jul 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 2

Arm	Type	Receives
Women with PCOS (PCOS group)	–	Other: No interventionPCOS women with obesity previously diagnosed with PCOS（meet the 2003 Rotterdam diagnostic criteria） not using hormonal therapy and without other significant health or endocrine issues.
Women without PCOS (Non-PCOS group)	–	Other: No interventionThis study enrolled age- and body mass index (BMI)-matched subjects with normal menstrual cycles, not using hormonal therapy, and without any significant health or endocrine issues.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult
Study population: This study enrolled 63 PCOS women with obesity and 58 age- and body mass index (BMI)-matched subjects with normal menstrual cycles who were admitted to the Department of Endocrinology, Shanghai Tenth People's Hospital, between April 2019 and November 2022.

Key inclusion criteria (4 listed)

patients with obesity (BMI>28kg/m2)
aged 18-45 years
Diagnosis of PCOS
the Rotterdam diagnosis criteria (2003)

Key exclusion criteria (11 listed)

Pregnant women;
Hyperthyroidism or hypothyroidism
Severe liver and kidney function injury
Cancer patients;
Associated with severe infection, severe anemia, neutropenia and other blood system diseases;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionNo intervention	Other	Women with PCOS (PCOS group), Women without PCOS (Non-PCOS group)

Primary outcome

Phenotype differences in the Serum non-targeted metabolomics by LC-MS.
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze non-target metabolites.
Phenotype differences in the gut microbiome by metagenomic sequencing.
Time frame: Samples to be collected once per participant within 7 days of enrollment
Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing.
Phenotype differences in the transcriptome expression by mRNA-seq.
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Understand phenotypical differences from biological samples comparing women with and without PCOS. The researcher will collect and analyze Venipuncture blood for RNA. Differences in the expression of genes between the two groups of subjects, analysis to select possible pathogenic factors leading to the pathogenesis of PCOS.
Phenotype differences in the Serum targeted metabolomics by LC-MS.
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory to comprehensively analyze the target metabolite.

37 secondary outcomes

BMI
Time frame: Samples to be collected once per participant within 7 days of enrollment.
TT
Time frame: Samples to be collected once per participant within 7 days of enrollment.
LH
Time frame: Samples to be collected once per participant within 7 days of enrollment.
FSH
Time frame: Samples to be collected once per participant within 7 days of enrollment.
E2
Time frame: Samples to be collected once per participant within 7 days of enrollment.
PRL
Time frame: Samples to be collected once per participant within 7 days of enrollment.
HC
Time frame: Samples to be collected once per participant within 7 days of enrollment.
WC
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Waist/hip Ratio
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Menstrual cycles
Time frame: Samples to be collected once per participant within 7 days of enrollment.
FBG
Time frame: Samples to be collected once per participant within 7 days of enrollment.
PBG
Time frame: Samples to be collected once per participant within 7 days of enrollment.
FINS
Time frame: Samples to be collected once per participant within 7 days of enrollment.
PINS
Time frame: Samples to be collected once per participant within 7 days of enrollment.
ALT
Time frame: Samples to be collected once per participant within 7 days of enrollment.
AST
Time frame: Samples to be collected once per participant within 7 days of enrollment.
UA
Time frame: Samples to be collected once per participant within 7 days of enrollment.
CR
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Ferriman-Gallwey score
Time frame: Samples to be collected once per participant within 7 days of enrollment.
HOMA-IR
Time frame: Samples to be collected once per participant within 7 days of enrollment.
HbA1c (%)
Time frame: Samples to be collected once per participant within 7 days of enrollment.
γ-GT
Time frame: Samples to be collected once per participant within 7 days of enrollment.
BUN
Time frame: Samples to be collected once per participant within 7 days of enrollment.
SOD
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Interleukin 22, IL-22
Time frame: Samples to be collected once per participant within 7 days of enrollment.
Interleukin 6，IL-6
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
Interleukin 8， IL-8
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
Tumor Necrosis Factor， TNF
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
FT
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
DHEAS
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
SHBG
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
AD
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
LDL-c
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
HDL-c
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
TC
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
TG
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.
CRP
Time frame: Blood samples to be collected once per participant within 7 days of enrollment.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
Individual participant dataSharing planned: No

Related trials for Polycystic Ovary Syndrome

Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manna Zhang, Ph.D principal investigator

Department of Endocrinology, Shanghai Tenth People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Polycystic Ovary Syndrome, run by Zhang Manna at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phenotype differences in the Serum non-targeted metabolomics by LC-MS. (time frame: Samples to be collected once per participant within 7 days of enrollment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05468476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.