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Effect of Intensive Monitoring of Patients With Poorly Controlled Type 2 Diabetes With Different Glycemic Background

Completed
Conditions
Poor Glycemic Control
Type 2 Diabetes
Registration Number
NCT06385899
Lead Sponsor
Goztepe Prof Dr Suleyman Yalcın City Hospital
Brief 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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
266
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

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in HbA1c levels after 12 months treatmenttwelve months

Changes in HbA1c levels after 12 months treatment according to the predetermined HbA1c groups.

percentage of patients who reached the HbA1c target of equal to or below 7%twelve months

Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%

Secondary Outcome Measures
NameTimeMethod
The effect of education on the HbA1c changestwelve months

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.

The effect of weight loss on the HbA1c changestwelve months

The effect of weight loss on reaching HbA1c target of 7% will be compared

The effect of the level of physical activity on the HbA1c changestwelve months

Physical activity is graded into 4 levels. Levels will be compared in participants who reach target HbA1c level and who do not

The effect of depression on the HbA1c changestwelve months

The Beck Depression Index will be used to compare participants who reach the HbA1c target and those who do not

Trial Locations

Locations (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

🇹🇷

Istanbul, Turkey

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