Clinical trial NCT06586879: Psychiatric Comorbidities in Type 1 Diabetes Mellitus.
Official title: Psychiatric Comorbidities in Children and Adolescent Patients with Diabetes Mellitus Type 1.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescent Patients with type 1 diabetes medllitus aged 8-15 years old.

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.

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.

Primary outcomes:
measure: The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.
timeFrame: 2 years
measure: the prevalence of depression, anxiety and sleep disorder in children and adolescents with diabetes mellitus type 1
timeFrame: 2 years
Secondary outcomes:
measure: The impact of diabetes mellitus type 1 on quality of life.
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Dalia Mahran
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.