Clinical trial NCT02248467: Study of the Effect of Testosterone Treatment on Metabolic Parameters and Urinary Symptoms in Bariatric Patients
Official title: Study of the Effect of Testosterone Replacement Therapy on Metabolic Parameters, Prostatic Inflammation Symptoms and Lower Urinary Tract Symptoms (LUTS) in Hypogonadal Obese Subjects Eligible for Bariatric Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Hypogonadism
Prostatic Hyperplasia
Insulin Resistance
Keywords: Testosterone replacement therapy
Lead sponsor: University of Florence
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 100
Sex: MALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male adults subjects suffering from severe obesity in a waiting list for bariatric surgery for weight loss will be considered eligible.

The diagnosis of hypogonadism will be defined by levels of total testosterone \<12nmol / l or free testosterone \<225 pmol / L (calculated according to the formula of Vermeulen).

Brief summary: The primary purpose of the study is to evaluate, in obese and hypogonadal patients eligible for bariatric surgery, the effect of testosterone replacement therapy in improving lower urinary tract symptoms (LUTS) assessed using the IPSS (International Prostate Symptom Score) questionnaire, compared to hypogonadal untreated subjects and eugonadal subjects.

Detailed description: Primary objective:

- Evaluation in obese and hypogonadal patients candidates for bariatric surgery of the effect of testosterone replacement therapy in improving the symptoms of LUTS (assessed using the IPSS questionnaire) compared to hypogonadal untreated subjects and eugonadal subjects.

Secondary objectives:

* Evaluation of the effect of testosterone in obese and hypogonadal patients candidates for bariatric surgery in improving metabolic parameters (glycaemia, oral glucose tolerance test, HbA1c, total cholesterol, HDL cholesterol, triglycerides, arterial pressure, BMI, waist circumference) compared to hypogonadal untreated subjects and eugonadal subjects
* Evaluation of the effect of testosterone in obese and hypogonadal patients candidates for bariatric surgery in improving uroflowmetric parameters compared to hypogonadal untreated subjects and eugonadal subjects
* Evaluation of the effect of testosterone in obese and hypogonadal patients candidates for bariatric surgery on the ultrasound characteristics of the prostate (macro-calcifications, intraprostatic arterial velocity, volume of the prostate gland).
* Evaluation of the effect of testosterone in obese and hypogonadal patients candidates for bariatric surgery on pre-adipocytes isolated from visceral adipose tissue samples collected during surgical procedures, as compared to hypogonadal untreated subjects and eugonadal subjects.

Eligibility criteria: Inclusion Criteria:

* Male subjects
* Age between 25 and 65 years
* Obese men, candidate to a bariatric surgery (body mass index (BMI) is ≥40 kg/m2, or if their BMI is \>35 kg/m2 and they suffer from other life-threatening co-morbidities such as Type 2 Diabetes Mellitus, hypertension and cardiovascular disease)
* Men with LUTS defined by: IPSS ≥ 8.
* Evidence of a personally signed and dated informed consent

Exclusion Criteria:

* Bladder failure or Neurogenic bladder
* LUT disease (Urethral stenosis, diverticula)
* LUT surgery (Prostatectomy, bladder neck surgery, TURP)
* Severe systemic disease
* Previous or concomitant neoplasm
* Unable to consistently and accurately complete the protocol
* Abuse alcohol or drugs
* Psychiatric disease

Primary outcomes:
measure: IPSS score (LUTS) improvement
timeFrame: 1 yr after surgery
Secondary outcomes:
measure: Presence of Metabolic Syndrome
timeFrame: 1 yr after surgery
measure: Volumetric change of the prostate
timeFrame: 1 yr after surgery
measure: Change in the number of prostatic macrocalcifications
timeFrame: 1 yr after surgery
measure: Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate
timeFrame: 1 yr after surgery
measure: Improvement of sexual function
timeFrame: 1 yr after surgery
measure: Improvement of symptoms of hypogonadism
timeFrame: 1 yr after surgery
measure: Preadipocyte dysfunction assessed in preadipocyte isolated from visceral adipose tissue obtained during bariatric surgery
timeFrame: 1 yr after surgery
measure: Variations in histomorphometric and molecular parameters of hepatic tissue obtained during bariatric surgery
timeFrame: 1 yr after surgery
Other outcomes:
Locations:
city: Florence
country: Italy
facility: Ambulatori Medicina della Sessualità e Andrologia
Study officials:
affiliation: University of Florence
name: Mario Maggi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lotti F, Corona G, Colpi GM, Filimberti E, Degli Innocenti S, Mancini M, Baldi E, Noci I, Forti G, Adorini L, Maggi M. Elevated body mass index correlates with higher seminal plasma interleukin 8 levels and ultrasonographic abnormalities of the prostate in men attending an andrology clinic for infertility. J Endocrinol Invest. 2011 Nov;34(10):e336-42. doi: 10.3275/7855. Epub 2011 Jul 7.
citation: Filippi S, Vignozzi L, Morelli A, Chavalmane AK, Sarchielli E, Fibbi B, Saad F, Sandner P, Ruggiano P, Vannelli GB, Mannucci E, Maggi M. Testosterone partially ameliorates metabolic profile and erectile responsiveness to PDE5 inhibitors in an animal model of male metabolic syndrome. J Sex Med. 2009 Dec;6(12):3274-88. doi: 10.1111/j.1743-6109.2009.01467.x. Epub 2009 Sep 1.
citation: Vignozzi L, Morelli A, Sarchielli E, Comeglio P, Filippi S, Cellai I, Maneschi E, Serni S, Gacci M, Carini M, Piccinni MP, Saad F, Adorini L, Vannelli GB, Maggi M. Testosterone protects from metabolic syndrome-associated prostate inflammation: an experimental study in rabbit. J Endocrinol. 2012 Jan;212(1):71-84. doi: 10.1530/JOE-11-0289. Epub 2011 Oct 18.
citation: Maseroli E, Comeglio P, Corno C, Cellai I, Filippi S, Mello T, Galli A, Rapizzi E, Presenti L, Truglia MC, Lotti F, Facchiano E, Beltrame B, Lucchese M, Saad F, Rastrelli G, Maggi M, Vignozzi L. Testosterone treatment is associated with reduced adipose tissue dysfunction and nonalcoholic fatty liver disease in obese hypogonadal men. J Endocrinol Invest. 2021 Apr;44(4):819-842. doi: 10.1007/s40618-020-01381-8. Epub 2020 Aug 8.