Study of the Effect of Testosterone Treatment on Metabolic Parameters and Urinary Symptoms in Bariatric Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Obesity, Hypogonadism, Prostatic Hyperplasia, Insulin Resistance

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| eugonadal<br>50 eugonadal subjects | |
| untreated hypogonadal<br>25 asymptomatic hypogonadal subjects | |
| treated hypogonadal<br>25 symptomatic hypogonadal subjects treated - In the present study, we decided to monitor only sexual symptoms of androgen deficiency due to the fact that testosterone replacement therapy (TRT) should be expected to improve them in the time span until surgery. These patients will be treated with TRT as per clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS score (LUTS) improvement | For each patient the presence of an improvement of LUTS, assessed by IPSS score, will be evaluated by calculating the difference between the scores of the IPSS questionnaire administered at V1 compared to that administered to V0, V2 as compared to V1, or V3 as compared to V2. The mean of this change will be then compared between different groups (eugonadal; untreated hypogonadal; treated hypogonadal) | 1 yr after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Metabolic Syndrome | The diagnosis of MetS parameters will be re-evaluated to confirm the presence or absence (waist circumference, dyslipidemia, blood pressure, fasting plasma glucose) | 1 yr after surgery | 
| Volumetric change of the prostate |  | 1 yr after surgery | 
| Change in the number of prostatic macrocalcifications |  | 1 yr after surgery | 
| Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate |  | 1 yr after surgery | 
| Improvement of sexual function | Improvement of sexual function will be assessed by evaluating differences in the score obtained at the IIEF-5 (International Index of Erectile Function), a questionnaire which assesses erectile function by 5 questions with a score from 0 to 5, by giving 5 to the best erectile function. Scores range from 1 to 25, and a cut-off of 21 defines erectile dysfunction (score <21). | 1 yr after surgery | 
| Improvement of symptoms of hypogonadism | Improvement of sexual function will be assessed by evaluating differences in the score obtained at the AMS (Aging Male's symptoms). This questionnaire consists of 17 questions which investigate the disturbances of the psychological, somatic and sexual domain; for each question the patient gives a numerical answer ranging from 1 (no symptoms) to 5 (very severe symptoms). The assessment of symptoms is obtained from the numerical sum of 17 responses. The symptoms are classified as: • absent: score 17 to 26; • mild: score 27 to 36; • moderate: score 37 to 49; • severe: score ≥ 50. | 1 yr after surgery | 
| Preadipocyte dysfunction assessed in preadipocyte isolated from visceral adipose tissue obtained during bariatric surgery |  | 1 yr after surgery | 
| Variations in histomorphometric and molecular parameters of hepatic tissue obtained during bariatric surgery |  | 1 yr after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testosterone replacement therapy