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

Changi General Hospital

Status and phase: Completed; Phase 4

Conditions: Inflammation; Endothelial Dysfunction; Quality of Life; Sexual Dysfunction

Treatments: Behavioral: Exercise and diet

Study type: Interventional

Funder types: Other

Identifiers

NCT01554735

12200233

Details and patient eligibility

About

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.

Full description

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

Enrollment: 70 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

lifestyle counselling

Experimental group

Description:

exercise and diet counselling for weight loss

Treatment:

Behavioral: Exercise and diet