ObesityNCT02248467
Study of the Effect of Testosterone Treatment on Metabolic Parameters and Urinary Symptoms in Bariatric Patients
An observational study of Obesity and Hypogonadism, run by University of Florence at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years, men only
- Conditions the study is for
- Obesity, Hypogonadism, Prostatic Hyperplasia
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Obesity, Hypogonadism, Prostatic Hyperplasia, Insulin Resistance
- Keywords
- Testosterone replacement therapy
- Medical subject headings
- Obesity, Hypogonadism, Prostatic Hyperplasia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 yr after surgery
Secondary outcomes (8)
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)
Measured: 1 yr after surgery
Volumetric change of the prostate
Measured: 1 yr after surgery
Change in the number of prostatic macrocalcifications
Measured: 1 yr after surgery
Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate
Measured: 1 yr after surgery
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).
Measured: 1 yr after surgery
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.
Measured: 1 yr after surgery
Preadipocyte dysfunction assessed in preadipocyte isolated from visceral adipose tissue obtained during bariatric surgery
Measured: 1 yr after surgery
Variations in histomorphometric and molecular parameters of hepatic tissue obtained during bariatric surgery
Measured: 1 yr after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Maggi, University of Florence
- Investigators
- Mario Maggi, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248467
- Sponsor's protocol ID
- ANDRO-AOUC-2013-01
- Status last verified
- Oct 2018
- First submitted
- 17 Sep 2014
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21738005Filippi 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.
PubMed 19732305Vignozzi 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.
PubMed 22010203Maseroli E, Comeglio P, Corno C, Cellai I, Filippi S, Mello T, Galli A, Rapizzi E, Presenti L, Truglia MC, Lotti F, Facchiano E, Beltrame B, Lucchese M, Saad F, Rastrelli G, Maggi M, Vignozzi L. Testosterone treatment is associated with reduced adipose tissue dysfunction and nonalcoholic fatty liver disease in obese hypogonadal men. J Endocrinol Invest. 2021 Apr;44(4):819-842. doi: 10.1007/s40618-020-01381-8. Epub 2020 Aug 8.
PubMed 32772323
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02248467
- Acronym / sponsor ID
- ANDRO-AOUC-2013-01
- Conditions
- Obesity, Hypogonadism, Prostatic Hyperplasia, Insulin Resistance
- Keywords
- Testosterone replacement therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Bladder failure or Neurogenic bladder
- LUT disease (Urethral stenosis, diverticula)
- LUT surgery (Prostatectomy, bladder neck surgery, TURP)
- Severe systemic disease
- Previous or concomitant neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
8 secondary outcomes
Presence of Metabolic Syndrome
Time frame: 1 yr after surgery
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 symptoms of hypogonadism
Time frame: 1 yr after surgery
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Background: PubMed 21738005Lotti 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.
- Background: PubMed 19732305Filippi 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.
- Background: PubMed 22010203Vignozzi 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.
- Derived from this study: PubMed 32772323Maseroli E, Comeglio P, Corno C, Cellai I, Filippi S, Mello T, Galli A, Rapizzi E, Presenti L, Truglia MC, Lotti F, Facchiano E, Beltrame B, Lucchese M, Saad F, Rastrelli G, Maggi M, Vignozzi L. Testosterone treatment is associated with reduced adipose tissue dysfunction and nonalcoholic fatty liver disease in obese hypogonadal men. J Endocrinol Invest. 2021 Apr;44(4):819-842. doi: 10.1007/s40618-020-01381-8. Epub 2020 Aug 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Maggi principal investigator
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Hypogonadism, run by University of Florence at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPSS score (LUTS) improvement (time frame: 1 yr after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02248467, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.