HypertensionNCT07172399
Factors Associated With Pre-hypertension Among Children With Type 1 Diabetes Mellitus
An observational study of Hypertension, run by Sohag University at 1 site in Egypt.
Trial summary
blood pressure of diabetic patients will be measured Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- blood sampling and • BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jul 2025to 5 Aug 2026
- How long will I take part?
- 10 Months
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: cildren from 6 to 18 year old
Who may be able to join
- Children and adolescents aged 6 - 18 years, diagnosed with T1DM for at least 1 year and attending the Pediatric diabetes clinic at Sohag University Hospital will be included as cases.
Who cannot join
- Children and adolescents with T1DM associated with autoimmune hypothyroidism or celiac disease and those who had received any form of corticosteroids therapy for any reason in the last 6 months will be excluded.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Factors Associated With Pre-hypertension Among Children and Adolescent With Type 1 Diabetes Mellitus
blood pressure of diabetic patients will be measured
Read the detailed description
All the study participants will be examined for assessment of the height and weight using calibrated equipment, Body Mass Index (BMI) calculated and plotted against percentiles,Blood Pressure (BP) Measurement:
- BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.
- Appropriate cuff size will be used based on mid-arm circumference.
- Blood pressure will be measured in the non-dominant arm.
- BP will be measured three times on at least two different occasions, after 5 minutes of rest, in a seated position.
- The average of the readings will be recorded.
- Conditions
- Hypertension
- Being tested
- blood sampling, • BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
blood samples will be taken to discover if there is hyperlipedemia,hyperthrodism or acute kidney injury
• BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.Other
All the study participants will be examined for assessment of the height and weight using calibrated equipment, Body Mass Index ,blood pressure will be measured.
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
- BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.
- Appropriate cuff size will be used based on mid-arm circumference.
- Blood pressure will be measured in the non-dominant arm.
- BP will be measured three times on at least two different occasions, after 5 minutes of rest, in a seated position.
- The average of the readings will be recorded
- BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.
- Appropriate cuff size will be used based on mid-arm circumference.
- Blood pressure will be measured in the non-dominant arm.
- BP will be measured three times on at least two different occasions, after 5 minutes of rest, in a seated position.
- The average of the readings will be recorded
- BP will be measured using a calibrated, automated oscillometric device suitable for pediatric
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start26 Jul 2025
- Primary completion25 Jul 2026 (estimated)
- Study completion5 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 10 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Ibrahim, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172399
- Sponsor's protocol ID
- Soh-Med--25-7-6MS
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Factors Associated With Pre-hypertension Among Children and Adolescent With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07172399
- Acronym / sponsor ID
- Soh-Med--25-7-6MS
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 26 Jul 2025 (actual)
- Primary completion
- 25 Jul 2026 (estimated)
- Study completion
- 5 Aug 2026 (estimated)
- First posted
- 15 Sep 2025 (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.
blood pressure of diabetic patients will be measured
Detailed description
All the study participants will be examined for assessment of the height and weight using calibrated equipment, Body Mass Index (BMI) calculated and plotted against percentiles,Blood Pressure (BP) Measurement:
- BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.
- Appropriate cuff size will be used based on mid-arm circumference.
- Blood pressure will be measured in the non-dominant arm.
- BP will be measured three times on at least two different occasions, after 5 minutes of rest, in a seated position.
- The average of the readings will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 10 Months
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- cildren from 6 to 18 year old
Key inclusion criteria (1 listed)
- Children and adolescents aged 6 - 18 years, diagnosed with T1DM for at least 1 year and attending the Pediatric diabetes clinic at Sohag University Hospital will be included as cases.
Key exclusion criteria (2 listed)
- Children and adolescents with T1DM associated with autoimmune hypothyroidism or celiac disease and those who had received any form of corticosteroids therapy for any reason in the last 6 months will be excluded.
- -
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 |
|---|---|---|
| blood samplingblood samples will be taken to discover if there is hyperlipedemia,hyperthrodism or acute kidney injury | Procedure or surgery | – |
| • BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use.All the study participants will be examined for assessment of the height and weight using calibrated equipment, Body Mass Index ,blood pressure will be measured. | Other | – |
Primary outcome
blood pressure
Time frame: one year
* BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use. * Appropriate cuff size will be used based on mid-arm circumference. * Blood pressure will be measured in the non-dominant arm. * BP will be measured three times on at least two different occasions, after 5 minutes of rest, in a seated position. * The average of the readings will be recorded * BP will be measured using a calibrated, automated oscillometric device suitable for pediatric use. * Appropriate cuff size will be used based on mid-arm circumference. * Blood pressure will be measured in the non-dominant arm. * BP will be measured three times on at least two different occasions, after 5 minutes of rest, in a seated position. * The average of the readings will be recorded * BP will be measured using a calibrated, automated oscillometric device suitable for pediatric
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 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Sohag 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: one year). 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 15 Sep 2025.