Bariatric Surgery and Male Reproductive Function

NCT ID: NCT04237311

Last Updated: 2021-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2023-12-31

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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaihong Zhu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Central South University Third Xiangya Hospital

Locations

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The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Pengzhou Li, M.D.

Role: CONTACT

86-13975878920

Xiang Gao, M.M.

Role: CONTACT

86-15364008159

Facility Contacts

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Shaihong Zhu, M.D.

Role: primary

+86 15802537999

References

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Gao X, Li P, Wang G, Li W, Song Z, Zhu S, Zhu L. Effect of laparoscopic sleeve gastrectomy on male reproductive function in Chinese men with obesity: a prospective cohort study. Int J Surg. 2024 Jun 1;110(6):3373-3381. doi: 10.1097/JS9.0000000000001328.

Reference Type DERIVED
PMID: 38477110 (View on PubMed)

Other Identifiers

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20191107

Identifier Type: -

Identifier Source: org_study_id

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