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

NCT01642576 | Completed Phase 4

• 1 other identifier: ZCHOENFU
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sexual Dysfunction; Endothelial Dysfunction; Quality of Life; Inflammation

Keywords

obesity; men; sexual function; urinary tract symptoms; endothelial function; inflammation; quality of life

Outcome Measures

Primary Outcomes (1)

• erectile function

  IIEF-5 score

  8 months

Secondary Outcomes (1)

• lower urinary tract symptoms

  8 months

Study Arms (2)

diet modification

EXPERIMENTAL

counselling on caloric restriction and healthy eating

Behavioral: weight loss counselling

weight management program

EXPERIMENTAL

dietician and sports trainer, physician counselling on weight loss

Behavioral: weight loss counselling

Interventions

weight loss counselling BEHAVIORAL

Diet counselling with or without sports trainers, over 8 months

diet modification; weight management program

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male, aged 30-65 years
• Body Mass Index (BMI) \>/= 27.5 kg/m2
• Waist circumference (WC) \>/= 90 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Inflammation; Obesity; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Joan Khoo, MRCP

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

SG (1)