Bariatric Surgery and Male Reproductive Function

Obesity Clinical Trial

Official title:

Effect and Mechanism of Bariatric Surgery on Male Reproductive Function

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04237311
• Other study ID #: 20191107
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: March 2021
• Source: The Third Xiangya Hospital of Central South University
• Contact: Pengzhou Li, M.D.
• Phone: 86-13975878920
• Email: lipengzhoulpz[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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).

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a-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	Concentration of interleukin in plasma	interleukin 6, interleukin 8, tumor necrosis factor-a	baseline- 3 months -6 months-12 months-2 years-3years
Secondary	Change of body mass index Body constant	Body mass index=weight(kg)/ height(m2)	baseline- 3 months -6 months-12 months-2 years-3years
Secondary	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
Secondary	Changes of micronutrient	Copper, Zinc, Calcium, Magnesium, Iron, Selenium.	baseline- 3 months -6 months-12 months-2 years-3years
Secondary	Changes of sex hormone	Testosterone, estradiol, luteinizing hormone, prolactin, follicle stimulating hormone, progesterone.	baseline- 3 months -6 months-12 months-2 years-3years
Secondary	Changes of Blood lipids	High density lipoprotein; low density lipoprotein; cholesterol; triglyceride	baseline- 3 months -6 months-12 months-2 years-3years
Secondary	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
Secondary	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
Secondary	Changes Waist to hip ratio	Waist to hip ratio(WHR)=waist(cm)/hip(cm)	baseline- 3 months -6 months-12 months-2 years-3years
Secondary	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 a-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