ObesityNCT06716125
Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus
A study testing aerobic treadmill walking plus low calorie diet and low calorie diet in people with Obesity and Tinnitus, Subjective, run by Cairo University at 1 site in Egypt.
Trial summary
obese male usually complain subjective tinnitus that may affect their sexual function. Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Obesity, Tinnitus, Subjective, Erectile Dysfunction
- What is being tested?
- aerobic treadmill walking plus low calorie diet and low calorie diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Nov 2024to 6 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- cardiac diseased males
- respiratory diseased males
- hepatic, musculoskeletal, and hepatic diseased males
- diabetic males
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate, 11432
Ali MA Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
ahmed elfahl, lecturer, +201001891218, ahmed.elfahl@buc.edu.eg
About this study
obese male usually complain subjective tinnitus that may affect their sexual function.
Read the 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).
- Conditions
- Obesity, Tinnitus, Subjective, Erectile Dysfunction
- Being tested
- aerobic treadmill walking plus low calorie diet, low calorie diet
- Medical subject headings
- Obesity, Tinnitus, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic treadmill walking plus low calorie dietBehavioural
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).
low calorie dietBehavioural
this group (n =20 for the group) will administer low calorie diet for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | This group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks. Receives: Behavioral: aerobic treadmill walking plus low calorie diet |
| Group II | Active comparator | this group (n =20 for the group) will administer low calorie diet for 12 weeks Receives: Behavioral: low calorie diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
international index of erectile function
Arabic form that contain five question will be used
Measured: it will be assessed after 12 weeks
Secondary outcomes (8)
body mass index
it will be assessed at empty stomach and bladder
Measured: it will be assessed after 12 weeks
waist circumference
it will be assessed at level of umbilicus
Measured: it will be assessed after 12 weeks
visual analogue scale of severity of tinnitus
it will be 10-cm line that will be used to assess tinnitus severity
Measured: it will be assessed after 12 weeks
visual analogue scale of discomfort induced by tinnitus
it will be 10-cm line that will be used to assess discomfort induced by tinnitus
Measured: it will be assessed after 12 weeks
tinnitus handicap inventory
it is a questionnaire that will assess quality of life impacted by tinnitus
Measured: it will be assessed after 12 weeks
triglycerides
it will be measured in plasma
Measured: it will be measured after 12 weeks
high density lipoprotein
it will be measured in plasma
Measured: it will be measured after 12 weeks
atherogenic index
it will be assessed as and indicator of atherosclerotic status
Measured: it will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start6 Nov 2024
- Primary completion6 Apr 2025 (estimated)
- Study completion6 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716125
- Sponsor's protocol ID
- IRB00014233-16
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus
- ClinicalTrials.gov ID
- NCT06716125
- Acronym / sponsor ID
- IRB00014233-16
- Conditions
- Obesity, Tinnitus, Subjective, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- 6 Apr 2025 (estimated)
- Study completion
- 6 Apr 2025 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Behavioral: aerobic treadmill walking plus low calorie dietThis group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks. |
| Group II | Active comparator | Behavioral: low calorie dietthis group (n =20 for the group) will administer low calorie diet for 12 weeks |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- cardiac diseased males
- respiratory diseased males
- hepatic, musculoskeletal, and hepatic diseased males
- diabetic males
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic treadmill walking plus low calorie dietthis 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). | Behavioural | group I |
| low calorie dietthis group (n =20 for the group) will administer low calorie diet for 12 weeks | Behavioural | Group II |
Primary outcome
international index of erectile function
Time frame: it will be assessed after 12 weeks
Arabic form that contain five question will be used
8 secondary outcomes
body mass index
Time frame: it will be assessed after 12 weeks
waist circumference
Time frame: it will be assessed after 12 weeks
visual analogue scale of severity of tinnitus
Time frame: it will be assessed after 12 weeks
visual analogue scale of discomfort induced by tinnitus
Time frame: it will be assessed after 12 weeks
tinnitus handicap inventory
Time frame: it will be assessed after 12 weeks
triglycerides
Time frame: it will be measured after 12 weeks
high density lipoprotein
Time frame: it will be measured after 12 weeks
atherogenic index
Time frame: it will be measured after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic treadmill walking plus low calorie diet and low calorie diet in people with Obesity and Tinnitus, Subjective, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Isamil, Lecturer (0201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
international index of erectile function (time frame: it will be assessed after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.