Diabetes MellitusNCT06591962
The Comparison of Biopsychosocial Characteristics with and Without Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Questionnaire application for diabetes mellitus and Questionnaire application for without diabetes mellitus
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 20 Sep 2025
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals who come to the university hospital for routine controls.
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hacettepe University
Ankara, Altındağ, 06100
About this study
Official title: The Comparison of Biopsychosocial Characteristics of Individuals with Diabetes Mellitus and Without Diabetes Mellitus
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Questionnaire application for diabetes mellitus, Questionnaire application for without diabetes mellitus
- Keywords
- Diabetes Mellitus, biopsychosocial model, BETY-BQ, validity and reliability, anxiety, depression
- Medical subject headings
- Diabetes Mellitus, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire application for diabetes mellitusOther
Scales will be applied to individuals diagnosed with diabetes mellitus
Questionnaire application for without diabetes mellitusOther
Scales will be applied to individuals diagnosed without diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire application for 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. Receives: Other: Questionnaire application for without diabetes mellitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
BETY-Biopsychosocial Questionnaire
The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status.
Measured: Three months
Secondary outcomes (5)
Hospital Anxiety Depression Scale (HADS)
HADS consists of 14 items, 7 of which assess anxiety, and the other 7 determine depression. Each item is scored between 0-3, and the total is scored between 0-21. High scores indicate poor anxiety and depression levels.
Measured: Three months
Turkish version of the Multidimensional Diabetes Questionnaire
The questionnaire consists of 3 sections, 7 sub-dimensions, and 41 items. Each section is evaluated separately; there is no total score for the scale.
Section 1 focuses on the perception of diabetes and social support. It includes 16 items measured using a 7-point Likert-type scale.
Section 2 evaluates the level of supportive and non-supportive behaviors of the diabetic spouse or caregiver towards self-care activities, using a 7-point Likert-type scale with 12 items.
Section 3 assesses the perception of individual self-efficacy and outcome expectancy regarding managing the disease with 13 items measured on a Likert-type scale.
High scores in perceived self-efficacy and outcome indicate a high level of expectation.
Measured: Three months
Summary of Diabetes Self-Care Activities
The study participants were asked to report the frequency of their self-care activities, such as diet, exercise, blood glucose testing, foot care, and smoking, over the past seven days. They used a number line to indicate the number of days (between 0-7) for each activity, and smoking, they used a scale of 0 for nonsmokers and 1 for smokers, with an additional measure for the amount of cigarettes smoked. A higher score indicates a higher level of self-care activity.
Measured: Three months
Health Assessment Questionnaire (HAQ)
The Health Assessment Questionnaire evaluates the functionality of the individual using eight parameters and 20 items. The parameters are classified as dressing, standing, eating, walking, hygiene, reaching, grasping, and other activities. Each item is scored as 0 (without any difficulty), 1 (with some difficulty), 2 (with a lot of difficulty), and 3 (unable to do at all). The total score is between 0-3, with a high score indicating low functionality.
Measured: Three months
General Health Questionnaire (Euro QoL-5D)
The scale consists of 2 subsections. The first part, the EQ-5D-Index, consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to each dimension have three options; "no problem," "moderate problem," and "extreme problem." Index value results vary between "-0.59" and "1" points. "0" indicates death, and "1" indicates total health. Negative values indicate unconsciousness and bed dependency. The second part of the scale is the vertical visual analog scale (EQ-VAS), Which evaluates the subjective health perception of the individual between 0 and 100. Marked as the best health you can imagine and the worst health you can imagine.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start20 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion20 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orkun Tüfekçi, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591962
- Sponsor's protocol ID
- Go 23/634
- Status last verified
- Oct 2023
- First submitted
- 9 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will not be shared to protect the data of individuals
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Biopsychosocial Characteristics of Individuals with Diabetes Mellitus and Without Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06591962
- Acronym / sponsor ID
- Go 23/634
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, biopsychosocial model, BETY-BQ, validity and reliability, anxiety, depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 20 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals diagnosed with diabetes mellitus | – | Other: Questionnaire application for diabetes mellitusIndividuals with diabetes mellitus admitted to the internal medicine outpatient clinic of a university hospital. A questionnaire will be applied for diabetes mellitus. |
| Individuals without a diagnosis of diabetes mellitus | – | Other: Questionnaire application for without diabetes mellitusIndividuals without diabetes mellitus admitted to the internal medicine outpatient clinic of a university hospital. A questionnaire will be applied for without diabetes mellitus. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals who come to the university hospital for routine controls.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire application for diabetes mellitusScales will be applied to individuals diagnosed with diabetes mellitus | Other | Individuals diagnosed with diabetes mellitus |
| Questionnaire application for without diabetes mellitusScales will be applied to individuals diagnosed without diabetes mellitus | Other | Individuals without a diagnosis of diabetes mellitus |
Primary outcome
BETY-Biopsychosocial Questionnaire
Time frame: Three months
The biopsychosocial status of the individual is assessed with questions about pain, functionality, mood, sociability, sexuality, and sleep status. Each question consists of 30 items scored between 0-120 as '0 (never), 1 (yes rarely), 2 (yes sometimes), 3 (yes often), 4 (yes always)'. A high score indicates poor biopsychosocial status.
5 secondary outcomes
Hospital Anxiety Depression Scale (HADS)
Time frame: Three months
Turkish version of the Multidimensional Diabetes Questionnaire
Time frame: Three months
Summary of Diabetes Self-Care Activities
Time frame: Three months
Health Assessment Questionnaire (HAQ)
Time frame: Three months
General Health Questionnaire (Euro QoL-5D)
Time frame: Three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Will not be shared to protect the data of individuals
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orkun Tüfekçi, PT, PhD(c) (5319502648, orkuntf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BETY-Biopsychosocial Questionnaire (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.