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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 : Completed
First Posted : September 25, 2014
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mario Maggi, University of Florence

Tracking Information
First Submitted Date September 17, 2014
First Posted Date September 25, 2014
Last Update Posted Date October 12, 2018
Study Start Date May 2013
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 22, 2014)
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)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02248467 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 22, 2014)
  • 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)
  • Volumetric change of the prostate [ Time Frame: 1 yr after surgery ]
  • Change in the number of prostatic macrocalcifications [ Time Frame: 1 yr after surgery ]
  • Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate [ Time Frame: 1 yr after surgery ]
  • 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).
  • 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.
  • Preadipocyte dysfunction assessed in preadipocyte isolated from visceral adipose tissue obtained during bariatric surgery [ Time Frame: 1 yr after surgery ]
  • Variations in histomorphometric and molecular parameters of hepatic tissue obtained during bariatric surgery [ Time Frame: 1 yr after surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).

Condition
  • Obesity
  • Hypogonadism
  • Prostatic Hyperplasia
  • Insulin Resistance
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 22, 2014)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2018
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02248467
Other Study ID Numbers ANDRO-AOUC-2013-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mario Maggi, University of Florence
Study Sponsor University of Florence
Collaborators Not Provided
Investigators
Principal Investigator: Mario Maggi University of Florence
PRS Account University of Florence
Verification Date October 2018