Psychiatric Comorbidities in Type 1 Diabetes Mellitus.

NCT ID: NCT06586879

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2026-09-30

Brief Summary

This study aimed to assess the prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.

Assessing the impact of diabetes mellitus type 1 on quality of life. And determine the effect of associated factors on the development of psychiatric comorbidities and on quality of life in diabetes mellitus type 1.

Detailed Description

Type 1 diabetes mellitus (TDM) is a chronic autoimmune disease. that affected carbohydrate metabolism and caused by insulin insufficiency resulting in increased blood glucose. It's one of the most common endocrine and metabolic conditions in childhood. There's 9 million people live with T1DM worldwide according to International Diabetes Federation. In Egypt, 1 in 98 families are impacted and the disease is growing at 6.7% each year. Living with T1DM has been associated with a significant impact on a person's social, mental, and psychological quality of life (QoL). as the individual must adopt blood glucose monitoring, use of injections or diabetes technology for insulin regulation, diet restrictions, and exercise. Also, there's increased risk of developing micro-and macro-vascular complications that result in morbidity and mortality in Long-term uncontrolled DM. therefore, these children and adolescents with T1DM have an increased risk of psychiatric comorbidities like depression, anxiety and sleep disorders, depression is one of the most common disorders. They appear to have a greater incidence of depression, anxiety and poor health-related quality of life (HRQoL) compared to their healthy peers. This is associated with suboptimal diabetes outcomes and better metabolic control has been found to correlate with better quality of life. This occurs especially when diagnosed at earlier age of onset, history of severe hypoglycemia and chronic hyperglycemia. There are no available studies that assess the presence of psychiatric comorbidities in T1DM in our locality.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• Children and adolescents aged between 8 and 15 years, diagnosed with diabetes mellitus type 1 and on medical treatment.

Exclusion Criteria

• Patients with major psychiatric disorders or have cognitive difficulties.
• Patients unable or refuse to give consent.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Omnia Mohamed Fath-Allah

Resident doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dalia Mahran

Role: STUDY_DIRECTOR

Assiut University

Central Contacts

Omnia Fath-Allah, Physician

Role: CONTACT

omnaya.16266093@med.aun.edu.eg

+201012304476

References

Ashraf MN, Cheng AYY, Robinson DJ. Emotional, Psychological, and Social Well-being Experience of Long-Term Living with Type 1 Diabetes Mellitus: A Patient-Psychiatrist-Endocrinologist Perspective. Diabetes Ther. 2024 Feb;15(2):317-323. doi: 10.1007/s13300-023-01527-w. Epub 2024 Jan 17.

Reference Type: BACKGROUND

PMID: 38233629 (View on PubMed)

Abouzid MR, Ali K, Elkhawas I, Elshafei SM. An Overview of Diabetes Mellitus in Egypt and the Significance of Integrating Preventive Cardiology in Diabetes Management. Cureus. 2022 Jul 20;14(7):e27066. doi: 10.7759/cureus.27066. eCollection 2022 Jul.

Reference Type: BACKGROUND

PMID: 36000101 (View on PubMed)

El-Ziny MA, Salem NA, El-Hawary AK, Chalaby NM, Elsharkawy AA. Epidemiology of childhood type 1 diabetes mellitus in Nile Delta, northern Egypt - a retrospective study. J Clin Res Pediatr Endocrinol. 2014;6(1):9-15. doi: 10.4274/Jcrpe.1171.

Reference Type: BACKGROUND

PMID: 24637304 (View on PubMed)

Related Links

https://idf.org/about-diabetes/type-1-diabetes/

Type 1 diabetes in international diabetes Federation

https://www.t1dindex.org/countries/egypt/

Type 1 diabetes index

https://pubmed.ncbi.nlm.nih.gov/30058247/

Psychological care of children and adolescents with type 1 diabetes

https://pubmed.ncbi.nlm.nih.gov/30968638/

Evaluation of psychological characteristics of Turkish children with type 1 diabetes mellitus from two demographically and geographically distinct regions

https://pubmed.ncbi.nlm.nih.gov/31850538/

The cognitive and psychological effects of living with type 1 diabetes

https://pubmed.ncbi.nlm.nih.gov/34770232/

High Rate of Depression among Saudi Children with Type 1 Diabetes

https://pubmed.ncbi.nlm.nih.gov/23057390/

Updating and validation of the socioeconomic status scale for health research in Egypt

https://www.ncbi.nlm.nih.gov/books/NBK507713/

Type 1 Diabetes

https://pubmed.ncbi.nlm.nih.gov/9204677/

Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data

https://www.apa.org/obesity-guideline/depression-inventory.pdf

Children's Depression Inventory 2nd Edition

https://pubmed.ncbi.nlm.nih.gov/9648330/

A measure of anxiety symptoms among children

https://njaap.org/wp-content/uploads/2016/04/Childrens-Sleep-Habits-Questionnaire.pdf

CHILDREN'S SLEEP HABITS QUESTIONNAIRE (ABBREVIATED)

https://pubmed.ncbi.nlm.nih.gov/11977437/

The PedsQL 4.0 Generic Core Scales:

Other Identifiers

Psychiatry in type 1 DM

Identifier Type: -

Identifier Source: org_study_id