The Comparison of Biopsychosocial Characteristics with and Without Diabetes Mellitus

Last updated: September 10, 2024
Sponsor: Hacettepe University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

Questionnaire application for diabetes mellitus

Questionnaire application for without diabetes mellitus

Clinical Study ID

NCT06591962
Go 23/634
  • Ages 18-65
  • All Genders

Study Summary

As it is a chronic disease, the lifelong disease duration and treatment process affect individuals with Type 2 Diabetes Mellitus (T2DM) biologically, psychologically, and socially by causing them to experience fatigue, increased stress, and life burden. Individuals with T2DM experience many psychosocial conditions leading to anxiety and depression as well as physical and functional effects. It has been reported that the fear of diabetic complications plays a vital role in depression, while individuals with diabetes with anxiety are more prone to depression. In addition, increased treatment cost burden has been reported among the psychological factors contributing to anxiety and depression in individuals with DM. One study reported that fatigue is commonly associated with increased anxiety, depression, and sleep problems in individuals with DM. A sedentary lifestyle in these individuals is noteworthy and has also been shown to be a contributing factor to depression.

In addition to improving diabetic complications due to the disease, reducing depressive states and improving the psychosocial status of individuals may positively affect diabetes and reduce the symptoms and complications of T2DM. It has also been reported that increasing the self-efficacy of individuals with diabetes may positively impact the treatment. Based on this information, it is clear that there is a need for physical and psychosocial evaluation of individuals with T2DM in disease management. Therefore, determination of the biopsychosocial effects of individuals with T2DM in improving disease-specific findings and quality of life of individuals with T2DM to reflect positively on disease management processes is necessary for holistic management in treating these individuals. However, studies in this field are insufficient. This study aimed to compare individuals with and without T2DM biopsychosocial characteristics.

The BETY-Biopsychosocial Questionnaire, which assesses the biopsychosocial status of individuals with rheumatism, has no validity in individuals with T2DM. Since the patient population and other scales to be used are common, it was considered to carry out the validity, reliability, and responsiveness study of this scale within the scope of this study.

Eligibility Criteria

Inclusion

Individuals with Diabetes Mellitus

Inclusion Criteria:

  • Being T2 DM

  • To be between 18-65 years old

Exclusion

Exclusion Criteria:

  • The patient has a diagnosis of autoimmune monogenic or drug-associated diabetes,

  • Lack of consent of the participants,

  • Frailty (Clinical Frailty Score; if greater than 3),

  • Stroke, heart failure (NYHA stage 3 and above), unstable lung and cardiovasculardiseases

Individuals without Diabetes Mellitus

Inclusion Criteria:

  • Not having T2DM (other individuals followed up at Hacettepe University -

  • Department of Internal Medicine)

  • To be between 18-65 years old

Exclusion Criteria:

  • The patient has a diagnosis of autoimmune monogenic or drug-associated diabetes,

  • Lack of consent of the participants,

  • Frailty (Clinical Frailty Score; if greater than 3),

  • Stroke, heart failure (NYHA stage 3 and above), unstable lung and cardiovasculardiseases

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Questionnaire application for diabetes mellitus
Phase:
Study Start date:
September 20, 2023
Estimated Completion Date:
September 20, 2025

Connect with a study center

  • Hacettepe University

    Ankara, Altındağ 06100
    Turkey

    Active - Recruiting

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