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

University of Florence (UNIFI)

Status: Completed

Conditions: Insulin Resistance; Obesity; Prostatic Hyperplasia; Hypogonadism

Study type: Observational

Funder types: Other

Identifiers

NCT02248467

ANDRO-AOUC-2013-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

eugonadal

Description:

50 eugonadal subjects

untreated hypogonadal

Description:

25 asymptomatic hypogonadal subjects

treated hypogonadal

Description:

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.