An observational study in Obesity, Diabetes Mellitus, Type 2 and Bariatric Surgery Candidate, sponsored by The Third Xiangya Hospital of Central South University. Status unknown at 1 site in China. Open to male participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by The Third Xiangya Hospital of Central South University · Observational
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 30 is below the median of 300 across 1,588 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
bariatric surgery male candidate
Exclusion Criteria:
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.
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).
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).
Time frame: 3 months after surgery
Concentration of interleukin in plasma
interleukin 6, interleukin 8, tumor necrosis factor-α
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Change of body mass index Body constant
Body mass index=weight(kg)/ height(m2)
Time frame: 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.
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes of micronutrient
Copper, Zinc, Calcium, Magnesium, Iron, Selenium.
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes of sex hormone
Testosterone, estradiol, luteinizing hormone, prolactin, follicle stimulating hormone, progesterone.
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes of Blood lipids
High density lipoprotein; low density lipoprotein; cholesterol; triglyceride
Time frame: 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.
Time frame: 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)
Time frame: baseline- 3 months -6 months-12 months-2 years-3years
Changes Waist to hip ratio
Waist to hip ratio(WHR)=waist(cm)/hip(cm)
Time frame: 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).
Time frame: baseline-6 months-12 months-2 years-3years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The Third Xiangya Hospital of Central South University