Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes

NCT ID: NCT05892848

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-10

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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cases group

childern and adolescents with type 1 diabetes

serum ostecalcin,serum sclerostin and parathroid profile

Intervention Type DIAGNOSTIC_TEST

evaluation of bone turnover markers in blood

control group

age and sex matched control childern and adolsecents

serum ostecalcin,serum sclerostin and parathroid profile

Intervention Type DIAGNOSTIC_TEST

evaluation of bone turnover markers in blood

Interventions

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serum ostecalcin,serum sclerostin and parathroid profile

evaluation of bone turnover markers in blood

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Hager Momen Ismail

Resident-pediatric department-sohag hospital university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Hajar M Ismail, resident

Role: CONTACT

01068447853

Ahmed M Monir, assistant professor

Role: CONTACT

Facility Contacts

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Magdy M Amin, professor

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 31819579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31840392 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33038875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30286569 (View on PubMed)

Other Identifiers

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Soh-Med-23-05-03MS

Identifier Type: -

Identifier Source: org_study_id

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