Obesity
Conditions
Keywords
Laparoscopic sleeve Gastrectomy, Nonalcoholic Fatty Liver, Type 2 Diabetes, Polycystic Ovary Syndrome, Acanthosis nigricans, Hyperuricemia, Hyperinsulinemia, Sleep apnea Syndrome
Brief summary
This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled.
Detailed description
This study aim to evaluate the clinical efficacy and safety after laparoscopic sleeve gastrectomy in patients with obesity. 300 patients with obesity and 49 healthy individuals with normal BMI were enrolled. All 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 assessed by FibroScan(CAP value and E value) were measured baseline and postoperative.
Interventions
bariatric surgery
Sponsors
Study design
Eligibility
Inclusion criteria
1\) age ranged from 16\ 65 years old, 2) 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
* 1\) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc., 2) pregnancy or lactation, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesions, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic steatosis | 3 years | hepatic steatosis assessed by FibroScan(CAP value and E value) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual cycles | 3 years | the total number of menstrual periods in the last year |
| 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 |
| BMI | 3 years | BMI=weight(kg)/height(m)\^2 |
| HOMA-IR | 3 years | Homeostatic model assessment insulin resistance index=FBG\*FINS/22.5 |
| HbA1c (%), | 3 years | Glycated hemoglobin |
| SHBG | 3 years | sex hormone-binding globulin in nmol/L |
| 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 |
| UA | 3 years | Uric acid in umol/L |