Bariatric Surgery and Male Reproductive Function

Sponsor

The Third Xiangya Hospital of Central South University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04237311

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Diabetes Mellitus, Type 2 Bariatric Surgery Candidate Roux en Y Gastric Bypass Sleeve Gastrectomy	Procedure: Sleeve gastrectomy Procedure: Roux-en-Y gastric bypass

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Effect and Mechanism of Bariatric Surgery on Male Reproductive Function

Actual Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 1, 2023

Outcome Measures

Primary Outcome Measures

Semen quality assessment [3 months after surgery]
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).

Secondary Outcome Measures

Concentration of interleukin in plasma [baseline- 3 months -6 months-12 months-2 years-3years]
interleukin 6, interleukin 8, tumor necrosis factor-α
Change of body mass index Body constant [baseline- 3 months -6 months-12 months-2 years-3years]
Body mass index=weight(kg)/ height(m2)
Changes of Vitamins [baseline- 3 months -6 months-12 months-2 years-3years]
Vitamin A, Vitamin B1, Vitamin B2, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D. Folic acid; Vitamin E.
Changes of micronutrient [baseline- 3 months -6 months-12 months-2 years-3years]
Copper, Zinc, Calcium, Magnesium, Iron, Selenium.
Changes of sex hormone [baseline- 3 months -6 months-12 months-2 years-3years]
Testosterone, estradiol, luteinizing hormone, prolactin, follicle stimulating hormone, progesterone.
Changes of Blood lipids [baseline- 3 months -6 months-12 months-2 years-3years]
High density lipoprotein; low density lipoprotein; cholesterol; triglyceride
Oral glucose tolerance test [baseline- 3 months -6 months-12 months-2 years-3years]
glucose-0,30,120min; C peptide-0,30,120min; insulin-0,30,120min.
Changes in International Index of Erectile Function-5 scale scores [baseline- 3 months -6 months-12 months-2 years-3years]
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)
Changes Waist to hip ratio [baseline- 3 months -6 months-12 months-2 years-3years]
Waist to hip ratio(WHR)=waist(cm)/hip(cm)
Semen quality assessment [baseline-6 months-12 months-2 years-3years]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China	410013

Sponsors and Collaborators

The Third Xiangya Hospital of Central South University

Investigators

Principal Investigator: Shaihong Zhu, M.D., Central South University Third Xiangya Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Third Xiangya Hospital of Central South University

ClinicalTrials.gov Identifier:

NCT04237311

Other Study ID Numbers:

20191107

First Posted:

Jan 23, 2020

Last Update Posted:

Mar 11, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Third Xiangya Hospital of Central South University

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 11, 2021