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临床试验/NCT06586879
NCT06586879尚未招募不适用

Psychiatric Comorbidities in Children and Adolescent Patients with Diabetes Mellitus Type 1.

Assiut University0 个研究点目标入组 220 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
220
主要终点
The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
8 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The prevalence of psychiatric comorbidities in children and adolescents with diabetes mellitus type 1.

时间窗: 2 years

This outcome will be measured using: The Kiddie-Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime (K-SADS-PL) version

the prevalence of depression, anxiety and sleep disorder in children and adolescents with diabetes mellitus type 1

时间窗: 2 years

this outcome will be measured using: 1. Children's Depression Inventory 2 Self Report-Short (CDI-2) (12) 2. The Spence Children's Anxiety Scale 3. Children's Sleep Habits Questionnaire (CSHQ)

次要结局

  • The impact of diabetes mellitus type 1 on quality of life.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Omnia Mohamed Fath-Allah

Resident doctor

Assiut University

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