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Trial record 49 of 59 for:    Recruiting, Not yet recruiting, Available Studies | "Prostatic Hyperplasia"

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

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ClinicalTrials.gov Identifier: NCT02248467
Recruitment Status : Recruiting
First Posted : September 25, 2014
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Mario Maggi, University of Florence

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.

Condition or disease
Obesity Hypogonadism Prostatic Hyperplasia Insulin Resistance

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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2013
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Group/Cohort
eugonadal
50 eugonadal subjects
untreated hypogonadal
25 asymptomatic hypogonadal subjects
treated hypogonadal
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.



Primary Outcome Measures :
  1. IPSS score (LUTS) improvement [ Time Frame: 1 yr after surgery ]
    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)


Secondary Outcome Measures :
  1. Presence of Metabolic Syndrome [ Time Frame: 1 yr after surgery ]
    The diagnosis of MetS parameters will be re-evaluated to confirm the presence or absence (waist circumference, dyslipidemia, blood pressure, fasting plasma glucose)

  2. Volumetric change of the prostate [ Time Frame: 1 yr after surgery ]
  3. Change in the number of prostatic macrocalcifications [ Time Frame: 1 yr after surgery ]
  4. Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate [ Time Frame: 1 yr after surgery ]
  5. Improvement of sexual function [ Time Frame: 1 yr after surgery ]
    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).

  6. Improvement of symptoms of hypogonadism [ Time Frame: 1 yr after surgery ]
    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.

  7. Preadipocyte dysfunction assessed in preadipocyte isolated from visceral adipose tissue obtained during bariatric surgery [ Time Frame: 1 yr after surgery ]
  8. Variations in histomorphometric and molecular parameters of hepatic tissue obtained during bariatric surgery [ Time Frame: 1 yr after surgery ]


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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248467


Contacts
Contact: Mario Maggi m.maggi@dfc.unifi.it

Locations
Italy
Ambulatori Medicina della Sessualità e Andrologia Recruiting
Florence, Italy
Contact: Mario Maggi       m.maggi@dfc.unifi.it   
Sub-Investigator: Elisa Maseroli         
Sub-Investigator: Linda Vignozzi         
Sub-Investigator: Marcello Lucchese         
Sub-Investigator: Enrico Facchiano         
Sponsors and Collaborators
University of Florence
Investigators
Principal Investigator: Mario Maggi University of Florence

Publications:
Responsible Party: Mario Maggi, Full Professor of Endocrinology, University of Florence
ClinicalTrials.gov Identifier: NCT02248467     History of Changes
Other Study ID Numbers: ANDRO-AOUC-2013-01
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by Mario Maggi, University of Florence:
Testosterone replacement therapy

Additional relevant MeSH terms:
Prostatic Hyperplasia
Insulin Resistance
Hyperplasia
Hypogonadism
Lower Urinary Tract Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Gonadal Disorders
Endocrine System Diseases
Urological Manifestations
Signs and Symptoms
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents