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

NCT05892848 | Unknown

• 1 other identifier: Soh-Med-23-05-03MS
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

cases group

childern and adolescents with type 1 diabetes

Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile

control group

age and sex matched control childern and adolsecents

Diagnostic Test: serum ostecalcin,serum sclerostin and parathroid profile

Interventions

serum ostecalcin,serum sclerostin and parathroid profile DIAGNOSTIC_TEST

evaluation of bone turnover markers in blood

cases group; control group

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• childern and adolescents with congenital bone disease, those with disorders of the parathyroid gland and those with chronic kidney disease.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 31819579 BACKGROUND

• 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.

  PMID: 31840392 BACKGROUND

• 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.

  PMID: 33038875 BACKGROUND

• 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.

  PMID: 30286569 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hajar M Ismail, resident

CONTACT

01068447853; hagermoamen@med.sohag.edu.eg

Ahmed M Monir, assistant professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-pediatric department-sohag hospital university

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 7, 2023
• Study Start: June 10, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-05

Locations

EG (1)