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Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus

Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06716125
Enrollment
40
Registered
2024-12-04
Start date
2024-11-06
Completion date
2025-04-06
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Obesity, Tinnitus, Subjective

Brief summary

obese male usually complain subjective tinnitus that may affect their sexual function.

Detailed description

this study will enroll forty obese males with subjective tinnitus (bilateral complaint) and sexual dysfunction (erectile dysfunction) who will be divided to group I and group II with an equal number of males within each group (n =20 for the group). all male in both groups will administer low calorie diet for 12 weeks but Group I will additionally administer supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks).

Interventions

BEHAVIORALaerobic treadmill walking plus low calorie diet

this group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking treadmill aerobic training for 45 minutes 3 times per week for 12 weeks).

BEHAVIORALlow calorie diet

this group (n =20 for the group) will administer low calorie diet for 12 weeks

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
35 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* obese person * body mass index less than 40 kg/m2 and more than 30 kg/m2 * males with subjective tinnitus (bilateral presentation from at least 24 weeks). * males with sexual dysfunction (erectile dysfunction from at least 24 weeks)

Exclusion criteria

* cardiac diseased males * respiratory diseased males * hepatic, musculoskeletal, and hepatic diseased males * diabetic males

Design outcomes

Primary

MeasureTime frameDescription
international index of erectile functionit will be assessed after 12 weeksArabic form that contain five question will be used

Secondary

MeasureTime frameDescription
waist circumferenceit will be assessed after 12 weeksit will be assessed at level of umbilicus
visual analogue scale of severity of tinnitusit will be assessed after 12 weeksit will be 10-cm line that will be used to assess tinnitus severity
visual analogue scale of discomfort induced by tinnitusit will be assessed after 12 weeksit will be 10-cm line that will be used to assess discomfort induced by tinnitus
body mass indexit will be assessed after 12 weeksit will be assessed at empty stomach and bladder
triglyceridesit will be measured after 12 weeksit will be measured in plasma
high density lipoproteinit will be measured after 12 weeksit will be measured in plasma
atherogenic indexit will be measured after 12 weeksit will be assessed as and indicator of atherosclerotic status
tinnitus handicap inventoryit will be assessed after 12 weeksit is a questionnaire that will assess quality of life impacted by tinnitus

Countries

Egypt

Contacts

Primary ContactAli Isamil, Lecturer
ali.mohamed@pt.cu.edu.eg0201005154209
Backup Contactahmed elfahl, Lecturer
ahmed.elfahl@buc.edu.eg0201001891218

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026