Polycystic Ovary Syndrome
Conditions
Keywords
Laparoscopic Sleeve Gastrectomy, Body fat distribution, Dual-energy X-ray absorptiometry, Visceral adipose tissue
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. Abdominal fat accumulation, overweightness and obesity are frequently present in patients with PCOS . Visceral adipose tissue (VAT) plays an important role in the pathogenesis of PCOS.Therefore，this study aim to investigate the changes of body fat distribution in obese women with PCOS after laparoscopic sleeve gastrectomy (LSG), and to explore the factors that may predict the changes in body fat distribution in PCOS patients after LSG.
Detailed description
This study consecutively enrolled 153 patients with obesity aged 18-45 years (83 with PCOS and 70 control patients) who underwent LSG from May 2013 to September 2020 at the Department of Endocrinology, Shanghai Tenth People's Hospital, with a 12-month follow-up. Dual-energy X-ray absorptiometry (DEXA) was used to assess body fat distribution.
Interventions
Multiple studies have indicated that laparoscopic sleeve gastrectomy (LSG) was superior to nonsurgical approaches for the treatment of obese PCOS patients over both the short and long term
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Fmale aged 18- 45; 2. Meet Rotterdam criteria(2003); 3. body mass index (BMI)≥30 kg/m2
Exclusion criteria
1. Gender is male; 2. Younger than 18 years old or older than 45 years old ; 3. secondary obesity due to endocrine disorders; 4. history of malignant tumors; 5）sever hepatic and renal disease; 6\) concurrent participation in other clinical trials; 7) sever endocrine and hereditary diseases; 8) mental illnesses that rendered them unable to provide informed consent; 9) patients declining to undergo complete study testing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAT mass | 12 months | visceral adipose tissue (VAT) mass |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FBG | 12 months | fasting blood-glucose in mmol/L |
| PBG | Baseline and 12 months | postprandial blood-glucose in mmol/L |
| FINS | Baseline and 12 months | fasting serum insulin in mU/L |
| PINS | Baseline and 12 months | postprandial insulin in mU/L |
| ALT | Baseline and 12 months | alanine aminotransferase in U/L |
| AST | Baseline and 12 months | aspartate aminotransferase in U/L） |
| UA | Baseline and 12 months | Uric acid in umol/L |
| CR | Baseline and 12 months | Creatinine in umol/L |
| LDL-c | Baseline and 12 months | low-density lipoprotein cholesterol in mmol/L |
| HDL-c | Baseline and 12 months | high-density lipoprotein cholesterol in mmol/L |
| TC | Baseline and 12 months | Total Cholesterol in mmol/L |
| TG | Baseline and 12 months | Triglyceride in mmol/L |
| BMI | 12 months | Body mass index (BMI) was calculated as follows: BMI = (body weight \[kg\])/(height \[m2\]) |
| HC | Baseline and 12 months | Hip circumference |
| Ferriman-Gallwey score | Baseline and 12 months | Ferriman-Gallwey score |
| Menstrual Cycles | Baseline and 12 months | The number of menstrual cycles per year was defined as the number of menstruations during the last 12 months. |
| HOMA-IR | Baseline and 12 months | homeostatic model assessment insulin resistance index |
| TT | Baseline and 12 months | total testosterone in nmol/L |
| FT | Baseline and 12 months | free testosterone (nmol/L) |
| DHEAS | Baseline and 12 months | Dehydroepiandrosterone Sulfate (ug/dl) |
| SHBG | Baseline and 12 months | sex hormone-binding globulin in nmol/L |
| FSH | Baseline and 12 months | follicle-stimulating hormone in IU/L |
| LH | Baseline and 12 months | luteinizing hormone in IU/L |
| WC | Baseline and 12 months | waist circumference, |
| WHR | Baseline and 12 months | waist-to-hip ratio (WHR) were calculated as follows: WHR = (waist circumference \[cm\]/(hip circumference \[cm\]). |
Countries
China
Outcome results
None listed