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

Obesity Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248467
• Other study ID #: ANDRO-AOUC-2013-01
• Status: Completed
• Start date: May 2013
• Est. completion date: June 2018

Study information

• Verified date: October 2018
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperplasia
• Hypogonadism
• Insulin Resistance
• Lower Urinary Tract Symptoms
• Obesity
• Prostatic Hyperplasia

Locations

Country	Name	City	State
Italy	Ambulatori Medicina della Sessualità e Andrologia	Florence

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Filippi S, Vignozzi L, Morelli A, Chavalmane AK, Sarchielli E, Fibbi B, Saad F, Sandner P, Ruggiano P, Vannelli GB, Mannucci E, Maggi M. Testosterone partially ameliorates metabolic profile and erectile responsiveness to PDE5 inhibitors in an animal model of male metabolic syndrome. J Sex Med. 2009 Dec;6(12):3274-88. doi: 10.1111/j.1743-6109.2009.01467.x. Epub 2009 Sep 1. — View Citation

Lotti F, Corona G, Colpi GM, Filimberti E, Degli Innocenti S, Mancini M, Baldi E, Noci I, Forti G, Adorini L, Maggi M. Elevated body mass index correlates with higher seminal plasma interleukin 8 levels and ultrasonographic abnormalities of the prostate in men attending an andrology clinic for infertility. J Endocrinol Invest. 2011 Nov;34(10):e336-42. doi: 10.3275/7855. Epub 2011 Jul 7. — View Citation

Vignozzi L, Morelli A, Sarchielli E, Comeglio P, Filippi S, Cellai I, Maneschi E, Serni S, Gacci M, Carini M, Piccinni MP, Saad F, Adorini L, Vannelli GB, Maggi M. Testosterone protects from metabolic syndrome-associated prostate inflammation: an experimental study in rabbit. J Endocrinol. 2012 Jan;212(1):71-84. doi: 10.1530/JOE-11-0289. Epub 2011 Oct 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Volumetric change of the prostate		1 yr after surgery
Secondary	Change in the number of prostatic macrocalcifications		1 yr after surgery
Secondary	Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate		1 yr after surgery
Secondary	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
Secondary	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
Secondary	Preadipocyte dysfunction assessed in preadipocyte isolated from visceral adipose tissue obtained during bariatric surgery		1 yr after surgery
Secondary	Variations in histomorphometric and molecular parameters of hepatic tissue obtained during bariatric surgery		1 yr after surgery