Clinical trial · Interventional
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men
NCT01642576CI-TRIAL-00018694completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endothelial Dysfunction | — | UNRESOLVED | — |
| Inflammation | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| weight loss counselling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- diet modification
- description
- counselling on caloric restriction and healthy eating
- interventionNames
- Behavioral: weight loss counselling
- type
- EXPERIMENTAL
- label
- weight management program
- description
- dietician and sports trainer, physician counselling on weight loss
- interventionNames
- Behavioral: weight loss counselling
Primary outcomes (1)
- measure
- erectile function
- timeFrame
- 8 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.