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NCT Number: NCT02248467

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

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.

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Key information

Conditions

Obesity Body Weight Endocrine System Diseases Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Hypogonadism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urogenital Diseases

Age range

25 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Ambulatori Medicina della Sessualità e Andrologia

Florence, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Sep 25, 2014
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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