Polycystic Ovary Syndrome
Conditions
Brief summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Sleeve gastrectomy was an effective threapy for severe obesity patients. This study will evaluate the clinical efficacy of sleeve gastrectomy for obese patients with PCOS. Mealwhile, the specific mechanism of sleeve gastrectomy for improving obese patients with PCOS will be explored through multi-group analysis.
Interventions
PROCEDURElaparoscopic sleeve gastrectomy
laparoscopic sleeve gastrectomy
DRUGMetformin Pill
Metformin 1000mg bid
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
laparoscopic sleeve gastrectomy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* female aged 18- 45; * meet Rotterdam criteria; * BMI ≥ 28 kg /m2.
Exclusion criteria
* Women who are pregnant or have a pregnancy plan within six months; * Women who are reluctant to undergo metabolic surgery; * Congenital adrenocortical hyperplasia; * Hyperprolactinemia; * Hyperthyroidism or hypothyroidism; * Abnormal liver function (≥ 3 times of the upper limit of normal range); abnormal · Rrenal function (GFR\<60ml/min/1.73m2); * Adrenal or ovarian tumors secreting androgens; * Used contraceptives, metformin, GLP-1RA, pioglitazone and contraceptives in the last 3 month.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HOMA-IR | 3 months | Insulin resistance index |
| Screening of metabolites in plasma concentration in fasting condition | 3 months | The investigators will perform metabolites to identify the changes that may give rise to the disease. |
| Screening of transcriptome profile in plasma concentration in fasting condition | 3 months | The investigators will perform transcriptome profile to identify the changes that may give rise to the disease. |
| Screening of Microbiome in faeces | 3 months | The investigators will perform Microbiome to identify the changes that may give rise to the disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SHBG level | 3 months | SHBG (nmol/L). |
| FINS | 3 months | fasting insulin (IU/L) |
| HDL-c | 3 months | high-density lipoprotein cholesterol (mmol/L) |
| TG | 3 months | Triglycerides (mmol/L) |
| LDL-c | 3 months | low-density lipoprotein cholesterol (mmol/L) |
| TC | 3 months | Total cholesterol (mmol/L) |
| menstrual cycles | 3 months | menstrual frequency |
| Gonadotropin level | 3 months | LH(IU/L) , FSH (IU/L), |
| testosterone | 3 months | total testosterone (nmol/L), testosterone (nmol/L) |
Countries
China
Outcome results
None listed