Psychiatric Disorders Related to Diabetes Mellitus Type 1

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05477433

Collaborator

(none)

140

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The most common endocrine illness in children and adolescents is type 1 diabetes. It is distinguished by a lack of insulin synthesis and necessitates daily insulin injections to keep glucose levels under control. As a result, there are numerous medical approaches to its management, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycemic control during the previous three months and monitoring of blood glucose levels, which affect the patient's mental health and quality of life. Type 1 diabetes complications and poor quality of life are widespread. Diabetes therapy is difficult during puberty and adolescence. Adolescents with T1D have poor metabolic control and a higher rate of acute complications. Because the onset of adolescence is frequently associated with decreased adherence to therapy and an increased risk of psychological illnesses.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Type 1 Adolescents Psychiatric Disorders	Behavioral: diabetes mellitus type 1

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Adolescents in Egypt

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2025

Outcome Measures

Primary Outcome Measures

Measure frequency of sleep problems with diabetes mellitus type 1 [through study completion, an average of 1 year]
Measures frequency of psychiatric problems with diabetes mellitus type 1 [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Both males and females were included.
Age ranges from 10 to 19 years.
Willing of the parents or the caregivers to participate in the study.
Duration of T1DM of at least 1 year.

Exclusion Criteria

Adolescents with an intelligence quotient below 70.
Adolescents with a history of substance use or psychiatric disorders.
Adolescents with medical or other neurological conditions.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Gellan Karamalllah Ramadan Ahmed, lecturer of neurology and psychiatry,faculty of medicine, Assiut University

ClinicalTrials.gov Identifier:

NCT05477433

Other Study ID Numbers:

diabetes mellitus

First Posted:

Jul 28, 2022

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Mental Disorders

Problem Behavior

Study Results

No Results Posted as of Jul 28, 2022