Type 1 Diabetes Clinical Trial
Official title:
Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes
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.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | June 30, 2024 |
| Est. primary completion date | June 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 3 Years to 16 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Sohag university Hospital | Sohag |
| Lead Sponsor | Collaborator |
|---|---|
| Sohag University |
Egypt,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 12 months |
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