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Bariatric Surgery and Male Reproductive Function

C

Central South University

Status

Unknown

Conditions

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

Treatments

Procedure: Sleeve gastrectomy
Procedure: Roux-en-Y gastric bypass

Study type

Observational

Funder types

Other

Identifiers

NCT04237311
20191107

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Male

Ages

20 to 60 years old

Volunteers

No 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.

Trial contacts and locations

1

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Central trial contact

Pengzhou Li, M.D.; Xiang Gao, M.M.

Data sourced from clinicaltrials.gov

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