Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men

Study Overview
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Brief Summary
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This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.

Detailed Description
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This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced by exercise and diet, improves metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited from referrals to the Sports Medicine Centre in Changi General Hospital. The study will be conducted at the Sports Medicine Centre by trained medical investigators, dieticians and sports trainers.At baseline, 12 and 24 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive EndoPAT method, and validated questionnaires administered to assess changes in erectile function, sexual desire, LUTS and quality of life

Official Title
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The Effects of Lifestyle-modification Induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men

Conditions
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Sexual Dysfunction, Endothelial Dysfunction, Quality of Life, Inflammation

Intervention / Treatment
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* Behavioral: Exercise and diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, aged 30-65 years Body Mass Index (BMI) >/= 27.5 kg/m2 Waist circumference (WC) >/= 90 cm Exclusion Criteria: pituitary disease or cranial radiotherapy previous or current androgen replacement or deprivation therapy current treatment for sexual problems or LUTS glomerular filtration rate < 60 ml/min liver disease alcohol intake exceeding 500 g/week in the previous 12 months use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lifestyle counselling<br>exercise and diet counselling for weight loss | Behavioral: Exercise and diet<br>* 24 weeks of exercise and diet counselling<br>* Other names: Exercise training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erectile function | Increase in IIEF-5 score | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower urinary tract symptoms | decrease in IPSS score | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life