Diabetes MellitusNCT07366970
Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?
A study testing exercise and vitamin D intake and vitamin D intake in people with Diabetes Mellitus and Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Diabetes Mellitus, Erectile Dysfunction, Vitamin D Deficiency
- What is being tested?
- exercise and vitamin D intake and vitamin D intake
- 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
- 5 Dec 2025to 5 May 2026
- 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
- diabetic men (forty)
- type 2 diabetes
- complaint of erectile dysfucntion (chronic complaint more than 24 months)
- men with low vitamin D (deiciency in vitamin D)
Who cannot join
- cardiac patients
- respiratory disease patients
- renal disease
- liver disease
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
Cairo University
Dokki, Giza Governorate, 11432
ali AM Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
About this study
males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important
Read the detailed description
forty diabetic men (type 2) who complain presence of low vitamin D and impotence will be divided to group number I and group number II. Both groups will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve weeks.
- Being tested
- exercise and vitamin D intake, vitamin D intake
- Medical subject headings
- Diabetes Mellitus, Erectile Dysfunction, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise and vitamin D intakeBehavioural
twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve weeks.
vitamin D intakeOther
twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve weeks. Receives: Behavioral: exercise and vitamin D intake |
| group number 2 | Active comparator | twenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Receives: Other: vitamin D intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
international index of erectile function
questionnaire used to assess impotence
Measured: it will be measured after 12 weeks
Secondary outcomes (9)
glycated hemoglubin
it will be used to assess blood glcuose
Measured: It will be measured after 12 weeks
fasting blood glcuose
it will be used to assess blood glcuose in serum
Measured: It will be measured after 12 weeks
body mass index
it will be measured on empty stomach and bladder
Measured: It will be measured after 12 weeks
wasit circumference
it will be measured at umbilicus level
Measured: it will be measured after 12 weeks
high density lipoprotein
it will be measured in serum
Measured: It will be measured after 12 weeks
low density lipoprotein
it will be measured in serum
Measured: It will be measured after 12 weeks
triglycerides
it will be assessed in serum
Measured: It will be measured after 12 weeks
cholesterol
it will be assessed in serum
Measured: It will be measured after 12 weeks
25-hydroxyvitamin D
it will be assessed in serum as a metabolite of vitamin D
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 posted26 Jan 2026
- Study start5 Dec 2025
- Primary completion5 May 2026 (estimated)
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies 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 MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366970
- Sponsor's protocol ID
- IRB000-14233-64
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 26 Jan 2026
- 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?
- ClinicalTrials.gov ID
- NCT07366970
- Acronym / sponsor ID
- IRB000-14233-64
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 5 May 2026 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 26 Jan 2026 (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.
males with diabetes complain impotence in the presence of low vitamin D deficiency. pharacmological treatment of low vitamin D levels is necessary but changing lifestyle by performing exercise is also important
Detailed description
forty diabetic men (type 2) who complain presence of low vitamin D and impotence will be divided to group number I and group number II. Both groups will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve 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 number 1 | Experimental | Behavioral: exercise and vitamin D intaketwenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve weeks. |
| group number 2 | Active comparator | Other: vitamin D intaketwenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last 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)
- diabetic men (forty)
- type 2 diabetes
- complaint of erectile dysfucntion (chronic complaint more than 24 months)
- men with low vitamin D (deiciency in vitamin D)
Key exclusion criteria (4 listed)
- cardiac patients
- respiratory disease patients
- renal disease
- liver disease
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 |
|---|---|---|
| exercise and vitamin D intaketwenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. Additionally, Group number I will perform treadmill walking (one hour walking) with moderate intensity. This walking will be performed three times per designed week for twelve weeks. | Behavioural | group number 1 |
| vitamin D intaketwenty diabetic men (type 2) who complain presence of low vitamin D and impotence will be pharmacologically treated by administration of Cholecalciferol 200.000 I.U (will be taken every two weeks). this treatment will last for 12 weeks. | Other | group number 2 |
Primary outcome
international index of erectile function
Time frame: it will be measured after 12 weeks
questionnaire used to assess impotence
9 secondary outcomes
glycated hemoglubin
Time frame: It will be measured after 12 weeks
fasting blood glcuose
Time frame: It will be measured after 12 weeks
body mass index
Time frame: It will be measured after 12 weeks
wasit circumference
Time frame: it will be measured after 12 weeks
high density lipoprotein
Time frame: It will be measured after 12 weeks
low density lipoprotein
Time frame: It will be measured after 12 weeks
triglycerides
Time frame: It will be measured after 12 weeks
cholesterol
Time frame: It will be measured after 12 weeks
25-hydroxyvitamin D
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 26 Jan 2026.
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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 MA 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 exercise and vitamin D intake and vitamin D intake in people with Diabetes Mellitus and Erectile Dysfunction, 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 26 Jan 2026. 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 MA Ismail, lecturer (01005154209, 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 measured 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 26 Jan 2026.