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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468476
• Other study ID #: Multi-omics PCOS
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. The precise pathogenesis of PCOS remains unknown but is thought to be multifactorial, comprising genetic and environmental factors .

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• patients with obesity (BMI>28kg/m2)

• aged 18-45 years

• Diagnosis of PCOS

• the Rotterdam diagnosis criteria (2003)

Exclusion Criteria:

• 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;

• 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.

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary Syndrome

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	Department of Endocrinology, Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhang Manna

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Samples to be collected once per participant within 7 days of enrollment.
Primary	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.	Samples to be collected once per participant within 7 days of enrollment
Primary	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.	Samples to be collected once per participant within 7 days of enrollment.
Primary	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.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	BMI	Body mass index (BMI)=weight(kg)/height(m)^2.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	TT	total testosterone in nmol/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	LH	luteinizing hormone in IU/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	FSH	The follicle-stimulating hormone in IU/l.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	E2	Estradiol in pmol/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	PRL	Prolactin in uIU/ml.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	HC	Hip Circumference in centimeters.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	WC	Waist Circumference in centimeters.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	Waist/hip Ratio	WHR=(Waist Circumference in centimeters)/(Hip Circumference in centimeters).	Samples to be collected once per participant within 7 days of enrollment.
Secondary	Menstrual cycles	the total number of menstrual periods in the last year.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	FBG	fasting blood-glucose in mmol/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	PBG	postprandial blood-glucose in mmol/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	FINS	fasting serum insulin in mU/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	PINS	postprandial insulin in mU/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	ALT	alanine aminotransferase in U/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	AST	aspartate aminotransferase in U/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	UA	Uric acid in umol/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	CR	Creatinine in umol/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	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.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	HOMA-IR	Homeostatic model assessment insulin resistance index=FBG*FINS/22.5.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	HbA1c (%)	glycosylated hemoglobin (%).	Samples to be collected once per participant within 7 days of enrollment.
Secondary	?-GT	?-glutamyl transferase in U/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	BUN	urea nitrogen in mmol/L.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	SOD	Superoxide dismutase in pg/ml.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	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.	Samples to be collected once per participant within 7 days of enrollment.
Secondary	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.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	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.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	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.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	FT	free testosterone in nmol/L.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	DHEAS	Dehydroepiandrosterone Sulfate in ug/dl.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	SHBG	sex hormone-binding globulin in nmol/L.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	AD	Androstenedione in ng/ml.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	LDL-c	low-density lipoprotein cholesterol in mmol/L.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	HDL-c	high-density lipoprotein cholesterol in mmol/L.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	TC	Total Cholesterol in mmol/L.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	TG	Triglyceride in mmol/L.	Blood samples to be collected once per participant within 7 days of enrollment.
Secondary	CRP	C reactive protein in pg/ml.	Blood samples to be collected once per participant within 7 days of enrollment.