- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07366970
Is There a Benefit From Addition of Exercise in Diabetic Patients With ED Who Complain Low Vitamin D?
January 17, 2026 updated by: Ali Mohamed Ali ismail, Cairo University
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
Study Overview
Status
Recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali MA Ismail, lecturer
- Phone Number: 01005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Contact Backup
- Name: Ali mohamed, lecturer
- Phone Number: 01031321109
- Email: fatmaraed1994@gmail.com
Study Locations
-
-
Giza Governorate
-
Dokki, Giza Governorate, Egypt, 11432
- Recruiting
- Cairo University
-
Contact:
- ali AM Ismail, lecturer
- Phone Number: +201005154209
- Email: ali.mohamed@pt.cu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- cardiac patients
- respiratory disease patients
- renal disease
- liver disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group number 1
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.
|
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.
|
|
Active Comparator: group number 2
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
international index of erectile function
Time Frame: it will be measured after 12 weeks
|
questionnaire used to assess impotence
|
it will be measured after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
triglycerides
Time Frame: It will be measured after 12 weeks
|
it will be assessed in serum
|
It will be measured after 12 weeks
|
|
glycated hemoglubin
Time Frame: It will be measured after 12 weeks
|
it will be used to assess blood glcuose
|
It will be measured after 12 weeks
|
|
fasting blood glcuose
Time Frame: It will be measured after 12 weeks
|
it will be used to assess blood glcuose in serum
|
It will be measured after 12 weeks
|
|
body mass index
Time Frame: It will be measured after 12 weeks
|
it will be measured on empty stomach and bladder
|
It will be measured after 12 weeks
|
|
wasit circumference
Time Frame: it will be measured after 12 weeks
|
it will be measured at umbilicus level
|
it will be measured after 12 weeks
|
|
high density lipoprotein
Time Frame: It will be measured after 12 weeks
|
it will be measured in serum
|
It will be measured after 12 weeks
|
|
low density lipoprotein
Time Frame: It will be measured after 12 weeks
|
it will be measured in serum
|
It will be measured after 12 weeks
|
|
cholesterol
Time Frame: It will be measured after 12 weeks
|
it will be assessed in serum
|
It will be measured after 12 weeks
|
|
25-hydroxyvitamin D
Time Frame: It will be measured after 12 weeks
|
it will be assessed in serum as a metabolite of vitamin D
|
It will be measured after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali MA Ismail, lecturer, Cairo University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2025
Primary Completion (Estimated)
May 5, 2026
Study Completion (Estimated)
May 5, 2026
Study Registration Dates
First Submitted
January 17, 2026
First Submitted That Met QC Criteria
January 17, 2026
First Posted (Actual)
January 26, 2026
Study Record Updates
Last Update Posted (Actual)
January 26, 2026
Last Update Submitted That Met QC Criteria
January 17, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Mental Disorders
- Nutrition Disorders
- Genital Diseases, Male
- Male Urogenital Diseases
- Metabolic Diseases
- Glucose Metabolism Disorders
- Sexual Dysfunction, Physiological
- Sexual Dysfunctions, Psychological
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Nutritional and Metabolic Diseases
- Diabetes Mellitus
- Erectile Dysfunction
- Vitamin D Deficiency
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Exercise
Other Study ID Numbers
- IRB000-14233-64
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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