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

NCT01554735 | Completed Phase 4

• 1 other identifier: 12200233
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

  Increase in IIEF-5 score

  24 weeks

Secondary Outcomes (1)

• lower urinary tract symptoms

  24 weeks

Study Arms (1)

lifestyle counselling

EXPERIMENTAL

exercise and diet counselling for weight loss

Behavioral: Exercise and diet

Interventions

Exercise and diet BEHAVIORAL

24 weeks of exercise and diet counselling

Also known as: Diet advice, Exercise training

lifestyle counselling

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

Related Publications (1)

• Khoo J, Tian HH, Tan B, Chew K, Ng CS, Leong D, Teo RC, Chen RY. Comparing effects of low- and high-volume moderate-intensity exercise on sexual function and testosterone in obese men. J Sex Med. 2013 Jul;10(7):1823-32. doi: 10.1111/jsm.12154. Epub 2013 May 1.

  PMID: 23635309 DERIVED

MeSH Terms

Conditions

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

Interventions

Exercise; Diet; Nutrition Assessment

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Joan J Khoo, MRCP

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 15, 2012
• Study Start: July 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

SG (1)