Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic ovary syndrome, Laparoscopic sleeve gastrectomy, Obesity, menstrual cycle
Brief summary
This study aims to evaluate the clinical efficacy and safety in obese patients with Polycystic Ovary Syndrome after laparoscopic sleeve gastrectomy.
Detailed description
This study aims to evaluate the clinical efficacy and safety of laparoscopic sleeve gastrectomy in obese patients with Polycystic Ovary Syndrome（PCOS). About 100 obese patients with PCOS and 100 simple obese patients (without complications) were enrolled. All PCOS patients with obesity underwent LSG. A multidisciplinary team evaluated participants with obesity at baseline, 1, 3, 6, 12, 24, and 36 months after LSG. Anthropometrics, Metabolic indicators, sex hormones, menstruation，glucose-lipid metabolic markers, and hepatic steatosis were measured baseline and postoperative.
Interventions
PROCEDURELaparoscopic sleeve Gastrectomy
Laparoscopic sleeve Gastrectomy
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparison of obese patients with PCOS and simple obesity after laparoscopic sleeve gastrectomy
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* age ranged from 18\ 45 years old, * BMI over 37.5 kg/m2, or BMI over 32.5 kg/m2 with diabetes which meets the recommended cutoff for bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China.
Exclusion criteria
* outside of the 18-45 age range; * secondary obesity caused by endocrine disorders; * history of more than one bariatric procedure; * severe hepatic, renal or heart dysfunction; * mental illnesses or intellectual disability. * pregnancy or lactation * contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc.,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual cycles | 3 years | the total number of menstrual periods in the last year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FGF-19 | 3 years | fibroblast growth factor 19 |
| FGL-1 | 3 years | fibrinogen-like protein 1 |
| BMI | 3 years | BMI=weight(kg)/height(m)\^2 |
| Waist/hip Ratio | 3 years | WHR=Waist Circumference in centimeter/Hip Circumference in centimeter |
| TT | 3 years | total testosterone in nmol/L |
| FBG | 3 years | fasting blood-glucose in mmol/L |
| PBG | 3 years | postprandial blood-glucose in mmol/L |
| FINS | 3 years | fasting serum insulin in mU/L |
| PINS | 3 years | postprandial insulin in mU/L |
| ALT | 3 years | alanine aminotransferase in U/L |
| AST | 3 years | aspartate aminotransferase in U/L |
| UA | 3 years | Uric acid in umol/L |
| HOMA-IR | 3 years | Homeostatic model assessment insulin resistance index=FBG\*FINS/22.5 |
| HbA1c (%) | 3 years | Glycated hemoglobin |
| ZAG | 3 years | zinc-alpha2-glycoprotein |
| FT | 3 years | free testosterone (nmol/L) |
| DHEAS | 3 years | Dehydroepiandrosterone Sulfate (ug/dl) |
| LDL-C | 3 years | low-density lipoprotein cholesterol in mmol/L |
| HDL-C | 3 years | Hight-density lipoprotein cholesterol in mmol/L |
| Fertility | 3 years | sexual function, fertility |
| LH | 3 years | luteinizing hormone in IU/L |
| FSH | 3 years | follicle-stimulating hormone in IU/l |
| E2 | 3 years | Estradiol in pmol/L |
| PRL | 3 years | Prolactin in uIU/ml |
| CR | 3 years | Creatinine in umol/L |
| AD | 3 years | Androstenedione in ng/ml |
| TC | 3 years | Total Cholesterol (mmol/L) |
| TG | 3 years | Triglyceride (mmol/L) |
| SHBG | 3 years | sex hormone-binding globulin in nmol/L |
Outcome results
None listed