Type 1 DiabetesNCT05892848
Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Sohag University at 1 site in Egypt.
Trial summary
Type 1 diabetes is associated with many longterm complications as retinopathy,neuropathy and nephropathy. Recently, several studies have linked type 1 diabetes to bone fragility.Studies conducted on patients with type 1 diabetes have concluded that bone is negatively affected in type 1 diabetes with impaired bone… Read more about this study
- Who is it for?
- Ages 3 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- serum ostecalcin,serum sclerostin and parathroid profile
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included
Who may be able to join
- childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included
Who cannot join
- childern and adolescents with congenital bone disease, those with disorders of the parathyroid gland and those with chronic kidney disease.
Trial locations and contacts
1 site in 1 country.
Ahmed M Monir, assistant professor contact
About this study
Type 1 diabetes is associated with many longterm complications as retinopathy,neuropathy and nephropathy. Recently, several studies have linked type 1 diabetes to bone fragility.Studies conducted on patients with type 1 diabetes have concluded that bone is negatively affected in type 1 diabetes with impaired bone density,increased fracture risk and impaired bone turnover markers.
- Conditions
- Type 1 Diabetes
- Being tested
- serum ostecalcin,serum sclerostin and parathroid profile
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum ostecalcin,serum sclerostin and parathroid profileDiagnostic test
evaluation of bone turnover markers in blood
| Study group | Role | What they receive |
|---|---|---|
| cases group | childern and adolescents with type 1 diabetes Receives: Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile | |
| control group | age and sex matched control childern and adolsecents Receives: Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of serum ostecalcin, sclerostin in patients with type 1 diabetes ann d their age and sex matched control
markers of bone turnover in patients with type 1 diabetes and their matched control
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start10 Jun 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Momen Ismail, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892848
- Sponsor's protocol ID
- Soh-Med-23-05-03MS
- Status last verified
- May 2023
- First submitted
- 29 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Starup-Linde J, Hygum K, Harslof T, Langdahl B. Type 1 Diabetes and Bone Fragility: Links and Risks. Diabetes Metab Syndr Obes. 2019 Dec 3;12:2539-2547. doi: 10.2147/DMSO.S191091. eCollection 2019.
PubMed 31819579Madsen JOB, Herskin CW, Zerahn B, Jensen AK, Jorgensen NR, Olsen BS, Svensson J, Pociot F, Johannesen J. Bone turnover markers during the remission phase in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2020 Mar;21(2):366-376. doi: 10.1111/pedi.12963. Epub 2019 Dec 27.
PubMed 31840392El Amrousy D, El-Afify D, Shabana A. Relationship between bone turnover markers and oxidative stress in children with type 1 diabetes mellitus. Pediatr Res. 2021 Mar;89(4):878-881. doi: 10.1038/s41390-020-01197-5. Epub 2020 Oct 10.
PubMed 33038875Roh JG, Yoon JS, Park KJ, Lim JS, Lee HS, Hwang JS. Evaluation of bone mineral status in prepuberal children with newly diagnosed type 1 diabetes. Ann Pediatr Endocrinol Metab. 2018 Sep;23(3):136-140. doi: 10.6065/apem.2018.23.3.136. Epub 2018 Sep 28.
PubMed 30286569
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05892848
- Acronym / sponsor ID
- Soh-Med-23-05-03MS
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 Jun 2023 (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.
Type 1 diabetes is associated with many longterm complications as retinopathy,neuropathy and nephropathy. Recently, several studies have linked type 1 diabetes to bone fragility.Studies conducted on patients with type 1 diabetes have concluded that bone is negatively affected in type 1 diabetes with impaired bone density,increased fracture risk and impaired bone turnover markers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profilechildern and adolescents with type 1 diabetes |
| control group | – | Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profileage and sex matched control childern and adolsecents |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included
Key inclusion criteria (1 listed)
- childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included
Key exclusion criteria (1 listed)
- childern and adolescents with congenital bone disease, those with disorders of the parathyroid gland and those with chronic kidney 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 |
|---|---|---|
| serum ostecalcin,serum sclerostin and parathroid profileevaluation of bone turnover markers in blood | Diagnostic test | cases group, control group |
Primary outcome
level of serum ostecalcin, sclerostin in patients with type 1 diabetes ann d their age and sex matched control
Time frame: 12 months
markers of bone turnover in patients with type 1 diabetes and their matched control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Background: PubMed 31819579Starup-Linde J, Hygum K, Harslof T, Langdahl B. Type 1 Diabetes and Bone Fragility: Links and Risks. Diabetes Metab Syndr Obes. 2019 Dec 3;12:2539-2547. doi: 10.2147/DMSO.S191091. eCollection 2019.
- Background: PubMed 31840392Madsen JOB, Herskin CW, Zerahn B, Jensen AK, Jorgensen NR, Olsen BS, Svensson J, Pociot F, Johannesen J. Bone turnover markers during the remission phase in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2020 Mar;21(2):366-376. doi: 10.1111/pedi.12963. Epub 2019 Dec 27.
- Background: PubMed 33038875El Amrousy D, El-Afify D, Shabana A. Relationship between bone turnover markers and oxidative stress in children with type 1 diabetes mellitus. Pediatr Res. 2021 Mar;89(4):878-881. doi: 10.1038/s41390-020-01197-5. Epub 2020 Oct 10.
- Background: PubMed 30286569Roh JG, Yoon JS, Park KJ, Lim JS, Lee HS, Hwang JS. Evaluation of bone mineral status in prepuberal children with newly diagnosed type 1 diabetes. Ann Pediatr Endocrinol Metab. 2018 Sep;23(3):136-140. doi: 10.6065/apem.2018.23.3.136. Epub 2018 Sep 28.
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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.
Ahmed M Monir, assistant professor contact
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 Type 1 Diabetes, 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 1 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: status not confirmed, as of the sponsor's last update on 7 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hajar M Ismail, resident (01068447853, hagermoamen@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of serum ostecalcin, sclerostin in patients with type 1 diabetes ann d their age and sex matched control (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05892848, which also lists 4 linked publications.
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 7 Jun 2023.