Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes
Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05892848
Collaborator
(none)
100
1
12.7
7.9
Study Details
Study Description
Brief 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 density,increased fracture risk and impaired bone turnover markers.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes
Anticipated Study Start Date
:
Jun 10, 2023
Anticipated Primary Completion Date
:
Jun 30, 2024
Anticipated Study Completion Date
:
Jun 30, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| cases group childern and adolescents with type 1 diabetes |
Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile
evaluation of bone turnover markers in blood
|
| control group age and sex matched control childern and adolsecents |
Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile
evaluation of bone turnover markers in blood
|
Outcome Measures
Primary Outcome Measures
- level of serum ostecalcin, sclerostin in patients with type 1 diabetes ann d their age and sex matched control [12 months]
markers of bone turnover in patients with type 1 diabetes and their matched control
Eligibility Criteria
Criteria
Ages Eligible for Study:
3 Years
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- 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
Exclusion Criteria:
- childern and adolescents with congenital bone disease, those with disorders of the parathyroid gland and those with chronic kidney disease.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sohag university Hospital | Sohag | Egypt |
Sponsors and Collaborators
- Sohag University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- El 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.
- Madsen 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.
- Roh 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.
- 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.
Responsible Party:
Hager Momen Ismail,
Resident-pediatric department-sohag hospital university,
Sohag University
ClinicalTrials.gov Identifier:
NCT05892848
Other Study ID Numbers:
- Soh-Med-23-05-03MS
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: