NCT02248467已完成不适用
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.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- IPSS score (LUTS) improvement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •Evidence of a personally signed and dated informed consent
排除标准
- •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
结局指标
主要结局
IPSS score (LUTS) improvement
时间窗: 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)
次要结局
- Change in the number of prostatic macrocalcifications(1 yr after surgery)
- Change in the peak of arterial velocity at the colour-doppler ultrasound of the prostate(1 yr after surgery)
- Improvement of sexual function(1 yr after surgery)
- Improvement of symptoms of hypogonadism(1 yr after surgery)
- Preadipocyte dysfunction assessed in preadipocyte isolated from visceral adipose tissue obtained during bariatric surgery(1 yr after surgery)
- Variations in histomorphometric and molecular parameters of hepatic tissue obtained during bariatric surgery(1 yr after surgery)
- Presence of Metabolic Syndrome(1 yr after surgery)
- Volumetric change of the prostate(1 yr after surgery)
研究者
Mario Maggi
Full Professor of Endocrinology
University of Florence
研究点 (1)
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