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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06385899
Other study ID # : Poorly controlled T2DM-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date March 1, 2023

Study information

Verified date April 2024
Source Goztepe Prof Dr Suleyman Yalcin City Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In Turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. The rate of patients reaching the treatment target is 50%. The pandemic has also affected diabetic patients. It is aimed to determine the characteristics of patients with type 2 diabetes (HbA1c >=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 12 months.


Description:

Patients who applied to Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital Diabetes Polyclinics and have an HbA1c levels of >= 10% in their examinations will be admitted to the study. Detailed history, including medication usage and previous blood tests will be questioned. The patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (General practice physical activity questionnaire), and whether the participants have depression (Beck depression questionnaire). Anthropometric measurements will be taken, and biochemical data will be recorded. Patients will be grouped according to their previous HbA1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning. Diabetes follow-up will be continued by their respective physicians. The patients will be called again three months after their enrollment to record the most recent biochemical data. Patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined HbA1c groups. Again, according to the patient groups, the difference in HbA1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 266
Est. completion date March 1, 2023
Est. primary completion date January 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - diagnosed with type 2 diabetes - give consent to the study - accessibility to the previous and recent test results Exclusion Criteria: - acute infection or inflammation lasting more than a week - acute metabolic decompensation - unable to attend to the follow-ups - having non-thyroid endocrine diseases - active oncologic treatment

Study Design


Locations

Country Name City State
Turkey Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Goztepe Prof Dr Suleyman Yalcin City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in HbA1c levels after 12 months treatment Changes in HbA1c levels after 12 months treatment according to the predetermined HbA1c groups. twelve months
Primary percentage of patients who reached the HbA1c target of equal to or below 7% Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7% twelve months
Secondary The effect of education on the HbA1c changes Educational status may have an impact on HbA1c reduction. Participants who have reached the HbA1c target are compared in terms of their educational level and those who have not. twelve months
Secondary The effect of depression on the HbA1c changes The Beck Depression Index will be used to compare participants who reach the HbA1c target and those who do not twelve months
Secondary The effect of the level of physical activity on the HbA1c changes Physical activity is graded into 4 levels. Levels will be compared in participants who reach target HbA1c level and who do not twelve months
Secondary The effect of weight loss on the HbA1c changes The effect of weight loss on reaching HbA1c target of 7% will be compared twelve months
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