Clinical trial NCT04237311: Bariatric Surgery and Male Reproductive Function
Official title: Effect and Mechanism of Bariatric Surgery on Male Reproductive Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Diabetes Mellitus, Type 2
Bariatric Surgery Candidate
Roux en Y Gastric Bypass
Sleeve Gastrectomy
Keywords: Semen
Micronutrient
Inflammation
Nutrition
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: bariatric surgery male candidate

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Semen quality assessment
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Concentration of interleukin in plasma
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Change of body mass index Body constant
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Changes of Vitamins
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Changes of micronutrient
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Changes of sex hormone
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Changes of Blood lipids
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Oral glucose tolerance test
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Changes in International Index of Erectile Function-5 scale scores
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Changes Waist to hip ratio
timeFrame: baseline- 3 months -6 months-12 months-2 years-3years
measure: Semen quality assessment
timeFrame: baseline-6 months-12 months-2 years-3years
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University Third Xiangya Hospital
name: Shaihong Zhu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: