ObesityNCT04237311
Bariatric Surgery and Male Reproductive Function
An observational study of Obesity and Diabetes Mellitus, Type 2, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Obesity, Diabetes Mellitus, Type 2, Bariatric Surgery Candidate
- What is being tested?
- Sleeve gastrectomy and Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to Dec 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Study population: bariatric surgery male candidate
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Shaihong Zhu, M.D., +86 15802537999, leonyi1997@aliyun.com
Shaihong Zhu, M.D.
About this study
Official title: Effect and Mechanism of Bariatric Surgery on Male Reproductive Function
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.
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Bariatric Surgery Candidate, Roux en Y Gastric Bypass, Sleeve Gastrectomy
- Being tested
- Sleeve gastrectomy, Roux-en-Y gastric bypass
- Keywords
- Semen, Micronutrient, Inflammation, Nutrition
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
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 bypassProcedure or surgery
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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).
Measured: 3 months after surgery
Secondary outcomes (10)
Concentration of interleukin in plasma
interleukin 6, interleukin 8, tumor necrosis factor-α
Measured: baseline- 3 months -6 months-12 months-2 years-3years
Change of body mass index Body constant
Body mass index=weight(kg)/ height(m2)
Measured: baseline- 3 months -6 months-12 months-2 years-3years
Changes of Vitamins
Vitamin A, Vitamin B1, Vitamin B2, Vitamin B9, Vitamin B12, Vitamin C, Vitamin D. Folic acid; Vitamin E.
Measured: baseline- 3 months -6 months-12 months-2 years-3years
Changes of micronutrient
Copper, Zinc, Calcium, Magnesium, Iron, Selenium.
Measured: baseline- 3 months -6 months-12 months-2 years-3years
Changes of sex hormone
Testosterone, estradiol, luteinizing hormone, prolactin, follicle stimulating hormone, progesterone.
Measured: baseline- 3 months -6 months-12 months-2 years-3years
Changes of Blood lipids
High density lipoprotein; low density lipoprotein; cholesterol; triglyceride
Measured: baseline- 3 months -6 months-12 months-2 years-3years
Oral glucose tolerance test
glucose-0,30,120min; C peptide-0,30,120min; insulin-0,30,120min.
Measured: baseline- 3 months -6 months-12 months-2 years-3years
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)
Measured: baseline- 3 months -6 months-12 months-2 years-3years
Changes Waist to hip ratio
Waist to hip ratio(WHR)=waist(cm)/hip(cm)
Measured: baseline- 3 months -6 months-12 months-2 years-3years
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 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).
Measured: baseline-6 months-12 months-2 years-3years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 May 2020
- Primary completion31 Dec 2021 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaihong Zhu, M.D., Principal investigator, Central South University Third Xiangya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237311
- Sponsor's protocol ID
- 20191107
- Status last verified
- Mar 2021
- First submitted
- 25 Dec 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38477110
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Mechanism of Bariatric Surgery on Male Reproductive Function
- ClinicalTrials.gov ID
- NCT04237311
- Acronym / sponsor ID
- 20191107
- Conditions
- Obesity, Diabetes Mellitus, Type 2, Bariatric Surgery Candidate, Roux en Y Gastric Bypass, Sleeve Gastrectomy
- Keywords
- Semen, Micronutrient, Inflammation, Nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- bariatric surgery male candidate
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeve gastrectomyLaparoscopic 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. | Procedure or surgery | – |
| Roux-en-Y gastric bypassLaparoscopic 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). | Procedure or surgery | – |
Primary outcome
Semen quality assessment
Time frame: 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).
10 secondary outcomes
Concentration of interleukin in plasma
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Change of body mass index Body constant
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes of Vitamins
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes of micronutrient
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes of sex hormone
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes of Blood lipids
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Oral glucose tolerance test
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes in International Index of Erectile Function-5 scale scores
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes Waist to hip ratio
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Semen quality assessment
Time frame: baseline-6 months-12 months-2 years-3years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 38477110Gao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaihong Zhu, M.D. principal investigator
Central South University Third Xiangya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Diabetes Mellitus, Type 2, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pengzhou Li, M.D. (86-13975878920, lipengzhoulpz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semen quality assessment (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.