Bariatric Surgery and Male Reproductive Function

Study Overview
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Brief Summary
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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.

Official Title
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Effect and Mechanism of Bariatric Surgery on Male Reproductive Function

Conditions
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Obesity, Diabetes Mellitus, Type 2, Bariatric Surgery Candidate, Roux en Y Gastric Bypass, Sleeve Gastrectomy

Intervention / Treatment
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* Procedure: Sleeve gastrectomy
* Procedure: Roux-en-Y gastric bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the surgical indications according to the Chinese Guidelines for Surgical Treatment of Obesity and Type 2 Diabetes (2019 Edition). 20 years old< patient<60 years old. Male Exclusion Criteria: Incapacity of giving an informed consent. Drug and / or alcohol abuse. Scrotal injury and previous scrotal surgery. Use of phosphodiesterase-5 inhibitors. Mental illnesses that may affect compliance with clinical research, including dementia, active psychosis, major depression, or attempted suicide.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Sleeve gastrectomy|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.|
|Procedure: Roux-en-Y gastric bypass|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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Semen, Micronutrient, Inflammation, Nutrition