The Comparison of Biopsychosocial Characteristics with and Without Diabetes Mellitus

NCT ID: NCT06591962

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-20

Study Completion Date

2025-09-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Individuals diagnosed with diabetes mellitus

Individuals with diabetes mellitus admitted to the internal medicine outpatient clinic of a university hospital. A questionnaire will be applied for diabetes mellitus.

Questionnaire application for diabetes mellitus

Intervention Type OTHER

Scales will be applied to individuals diagnosed with diabetes mellitus

Individuals without a diagnosis of diabetes mellitus

Individuals without diabetes mellitus admitted to the internal medicine outpatient clinic of a university hospital. A questionnaire will be applied for without diabetes mellitus.

Questionnaire application for without diabetes mellitus

Intervention Type OTHER

Scales will be applied to individuals diagnosed without diabetes mellitus

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire application for diabetes mellitus

Scales will be applied to individuals diagnosed with diabetes mellitus

Intervention Type OTHER

Questionnaire application for without diabetes mellitus

Scales will be applied to individuals diagnosed without diabetes mellitus

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Being T2 DM
* To be between 18-65 years old


* 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 cardiovascular diseases

Individuals without Diabetes Mellitus


* 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 cardiovascular diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Orkun Tüfekçi

Principal Investigator, PT, PhD(c)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hacettepe University

Ankara, Altındağ, Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Orkun Tüfekçi, PT, PhD(c)

Role: CONTACT

5319502648

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Go 23/634

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.