Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men

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.

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Key information

Conditions

Sexual Dysfunction Body Weight Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Endothelial Dysfunction Genetic Diseases, Inborn Genital Diseases Inflammation Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Quality of Life Sexual Dysfunction, Physiological Signs and Symptoms Urogenital Diseases

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Changi General Hospital

Singapore, 529889

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

weight loss counselling

Behavioral

Diet counselling with or without sports trainers, over 8 months

Primary outcomes

erectile function

Time frame: 8 months

IIEF-5 score

Secondary outcomes

lower urinary tract symptoms

Time frame: 8 months

IPSS score

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Jul 17, 2012
Registry last updated: Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed