Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile 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: weight loss counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT01642576

ZCHOENFU

Details and patient eligibility

About

This study aims to compare the effects of 8 months of diet modification, with or without exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and quality of life in obese men.

Enrollment: 90 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: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

diet modification

Experimental group

Description:

counselling on caloric restriction and healthy eating

Treatment:

Behavioral: weight loss counselling

weight management program

Experimental group

Description:

dietician and sports trainer, physician counselling on weight loss

Treatment:

Behavioral: weight loss counselling