Clinical trial NCT06728644: The Role of L-arginine in Polycystic Ovary Syndrome
Official title: The Safety and Efficacy of L-arginine in Patients with Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
L-arginine
Gut Microbiome
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PCOS patients meeting the trial criteria were enrolled from the Shanghai 10th People's Hospital. The contents of this study were introduced to them, and they were invited to participate in the study. We further evaluated the efficacy and safety of arginine in treating PCOS by implementing the L-arginine clinical intervention protocol, and conducting post-intervention follow-up, efficacy evaluation, laboratory tests, and fecal sample 16S rRNA sequencing.

Detailed description: In this study, we will enroll PCOS patients who meet the trial criteria from the Shanghai 10th People's Hospital, introduce the content of this study to them, and invite them to participate in the study. Perform laboratory tests for PCOS and collect baseline stool and blood samples. The clinical intervention program of L-arginine was implemented, and post-intervention follow-up, efficacy evaluation and laboratory examination were carried out. Stool and blood samples were collected after the intervention, and 16S rRNA sequencing was performed on stool samples before and after the intervention. To analyze whether PCOS-related clinical and laboratory indicators improved after L-arginine treatment of PCOS, and to analyze the changes in patients' microbiome before and after L-arginine treatment, to clarify the effectiveness and safety of L-arginine treatment of PCOS.

Eligibility criteria: Inclusion Criteria:

* aged 18-45 years
* Diagnosis of PCOS with 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;
* Have a long history of taking hormone therapy;
* Currently or recently participating in another clinical trial.

Primary outcomes:
measure: menstrual frequency
timeFrame: Within 7 days of enrollment
Secondary outcomes:
measure: Homeostasis model assessment of insulin resistance
timeFrame: Within 7 days of enrollment
measure: body mass index
timeFrame: Within 7 days of enrollment.
measure: fasting glucose
timeFrame: Within 7 days of enrollment.
measure: fasting insulin
timeFrame: Within 7 days of enrollment.
measure: Total cholesterol
timeFrame: Within 7 days of enrollment.
measure: Triglycerides
timeFrame: Within 7 days of enrollment.
measure: HDL-c
timeFrame: Within 7 days of enrollment.
measure: LDL-c
timeFrame: Within 7 days of enrollment.
measure: total testosterone
timeFrame: Within 7 days of enrollment.
measure: free testosterone
timeFrame: Within 7 days of enrollment.
measure: Sex hormone-binding globulin
timeFrame: Within 7 days of enrollment.
measure: Androstenedione
timeFrame: Within 7 days of enrollment.
measure: Dehydroepiandrosterone
timeFrame: Within 7 days of enrollment.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Endocrinology, Shanghai Tenth People's Hospital
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Manna Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
References: