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Completed

NCT Number: NCT05394571

Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and HbA1c Changes With Therapy

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. We 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 3 months.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

About this study

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 they 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Changes in HbA1c levels after 3 months treatment

    Time frame: Three months

    Changes in HbA1c levels after 3 months treatment according to the predetermined HbA1c groups.

  2. Changes in HbA1c levels equal to or more than 20%

    Time frame: Three months

    Comparison of the patient groups according to the reduction of 20% or more in HbA1c levels.

  3. ratio of patients who reached the HbA1c target of equal to or below 7%

    Time frame: Three months

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

Secondary outcomes

  1. The effect of education on the HbA1c changes

    Time frame: Three months

    The effect of education on HbA1c changes and comparisons between the patient groups.

  2. The effect of depression on the HbA1c changes

    Time frame: Three months

    The effect of depression as evaluated with Beck depression test on HbA1c changes and comparisons between the patient groups.

  3. The effect of the level of physical activity on the HbA1c changes

    Time frame: Three months

    The effect of physical activity assessed by General practice physical activity questionnaire on HbA1c changes and comparisons between the patient groups.

Sponsors and collaborators

Lead sponsor

Goztepe Training and Research Hospital

Other

Registry information

Official study title

Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and Early Changes in HbA1c Values With Tailored Treatment

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 27, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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