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Obesity is a global public health problem. According to literature reports, as of 2016, China's obese population has reached more than 90 million and type 2 diabetes mellitus has reached more than 100 million, which has brought a serious health and economic burden to China. In addition to various health problems such as cardiovascular, osteoarthritis, and tumors, obesity can also cause abnormalities in reproductive endocrine. In women, it can cause abnormal menstruation, polycystic ovary syndrome, and male obesity can cause secondary gonadal. Hypofunction (MOSH). MOSH is an endocrine dysfunction. It is reported to have a prevalence of approximately 45% in moderate to severe obesity. In addition, studies have pointed out that the prevalence of hypogonadism in men with type 2 diabetes and obesity higher. However, there are no studies on the reproductive function of Chinese male patients after bariatric surgery. Pre- and post-operative semen will be collected for analysis to observe the effect of bariatric surgery on male reproductive function.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleeve gastrectomy | Procedure | Laparoscopic sleeve gastrectomy is performed as following: after greater curvature dissociating, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using linear cutting stapler of 3.5- or 4.8-mm-high staples, depending on gastric thickness. | ||
| Roux-en-Y gastric bypass | Procedure | Laparoscopic Roux-en-Y gastric bypass is performed as following: a gastric pouch of approximately 30mL was obtained using linear cutting stapler, the sum of the length of the alimentary limb and the biliopancreatic limb> 200 cm (can be adjusted according to the incidence of the patient's BMI, type 2 diabetes mellitus and the specific situation). |
| Measure | Description | Time Frame |
|---|---|---|
| Semen quality assessment | Semen quality assessment based the following indicators, including the time of liquefaction, semen PH, semen volume, sperm numbers, sperm vitality, sperm motility, sperm morphology, concentration of zinc in seminal plasma, concentration of fructose in seminal plasma, concentration of neutral α-glucosidase in seminal plasma, concentration of seminal elastase.The corresponding detection method is based on WHO laboratory manual for the Examination and processing of human semen(FIFTH EDITION). | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of interleukin in plasma | interleukin 6, interleukin 8, tumor necrosis factor-α | baseline- 3 months -6 months-12 months-2 years-3years |
| Change of body mass index Body constant | Body mass index=weight(kg)/ height(m2) |
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Inclusion Criteria:
Exclusion Criteria:
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bariatric surgery male candidate
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengzhou Li, M.D. | Contact | 86-13975878920 | lipengzhoulpz@163.com | |
| Xiang Gao, M.M. | Contact | 86-15364008159 | 791902939@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Shaihong Zhu, M.D. | Central South University Third Xiangya Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38477110 | Derived | Gao X, Li P, Wang G, Li W, Song Z, Zhu S, Zhu L. Effect of laparoscopic sleeve gastrectomy on male reproductive function in Chinese men with obesity: a prospective cohort study. Int J Surg. 2024 Jun 1;110(6):3373-3381. doi: 10.1097/JS9.0000000000001328. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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| baseline- 3 months -6 months-12 months-2 years-3years |
| Changes of Vitamins | Vitamin A, Vitamin B1, Vitamin B2, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D. Folic acid; Vitamin E. | baseline- 3 months -6 months-12 months-2 years-3years |
| Changes of micronutrient | Copper, Zinc, Calcium, Magnesium, Iron, Selenium. | baseline- 3 months -6 months-12 months-2 years-3years |
| Changes of sex hormone | Testosterone, estradiol, luteinizing hormone, prolactin, follicle stimulating hormone, progesterone. | baseline- 3 months -6 months-12 months-2 years-3years |
| Changes of Blood lipids | High density lipoprotein; low density lipoprotein; cholesterol; triglyceride | baseline- 3 months -6 months-12 months-2 years-3years |
| Oral glucose tolerance test | glucose-0,30,120min; C peptide-0,30,120min; insulin-0,30,120min. | baseline- 3 months -6 months-12 months-2 years-3years |
| Changes in International Index of Erectile Function-5 scale scores | minimum point 0, maximum points 25, (≥22 points are normal, 17-21 mild Erectile dysfunction, 12-16 moderateErectile dysfunction, 8-11 moderate Erectile dysfunction, <7 severe Erectile dysfunction) | baseline- 3 months -6 months-12 months-2 years-3years |
| Changes Waist to hip ratio | Waist to hip ratio(WHR)=waist(cm)/hip(cm) | baseline- 3 months -6 months-12 months-2 years-3years |
| Semen quality assessment | Semen quality assessment based the following indicators, including the time of liquefaction, semen PH, semen volume, sperm numbers, sperm vitality, sperm motility, sperm morphology, concentration of zinc in seminal plasma, concentration of fructose in seminal plasma, concentration of neutral α-glucosidase in seminal plasma, concentration of seminal elastase.The corresponding detection method is based on WHO laboratory manual for the Examination and processing of human semen(FIFTH EDITION). | baseline-6 months-12 months-2 years-3years |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |