Gut Microbiome, L-arginine, Polycystic Ovary Syndrome
Conditions
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.
Interventions
DRUGL-arginine intervention
L-arginine intervention for 3 months, 3 g per day.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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 a long history of taking hormone therapy; * Currently or recently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| menstrual frequency | Within 7 days of enrollment | number of menstruation in a year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| body mass index | Within 7 days of enrollment. | body mass index (kg/m2) |
| fasting glucose | Within 7 days of enrollment. | fasting glucose (mmol/L) |
| fasting insulin | Within 7 days of enrollment. | fasting insulin (mmol/L) |
| Total cholesterol | Within 7 days of enrollment. | Total cholesterol (mmol/L) |
| Triglycerides | Within 7 days of enrollment. | Triglycerides (mmol/L) |
| HDL-c | Within 7 days of enrollment. | HDL-c (mmol/L) |
| Homeostasis model assessment of insulin resistance | Within 7 days of enrollment | insulin resistance index |
| total testosterone | Within 7 days of enrollment. | total testosterone (nmol/L) |
| free testosterone | Within 7 days of enrollment. | free testosterone (nmol/L) |
| Sex hormone-binding globulin | Within 7 days of enrollment. | Sex hormone-binding globulin (nmol/L) |
| Androstenedione | Within 7 days of enrollment. | Androstenedione (ng/ml) |
| Dehydroepiandrosterone | Within 7 days of enrollment. | Dehydroepiandrosterone (ug/dl) |
| LDL-c | Within 7 days of enrollment. | LDL-c (mmol/L) |
Countries
China
Outcome results
None listed