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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05394571
Enrollment
250
Registered
2022-05-27
Start date
2021-08-15
Completion date
2022-07-30
Last updated
2022-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Poorly Controlled Diabetes Mellitus, Type 2 Diabetes

Keywords

type 2 diabetes, poorly controlled Diabetes Mellitus

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. 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.

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 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.

Interventions

None listed

Sponsors

Goztepe Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in HbA1c levels after 3 months treatmentThree monthsChanges in HbA1c levels after 3 months treatment according to the predetermined HbA1c groups.
Changes in HbA1c levels equal to or more than 20%Three monthsComparison of the patient groups according to the reduction of 20% or more in HbA1c levels.
ratio of patients who reached the HbA1c target of equal to or below 7%Three monthsComparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%.

Secondary

MeasureTime frameDescription
The effect of education on the HbA1c changesThree monthsThe effect of education on HbA1c changes and comparisons between the patient groups.
The effect of depression on the HbA1c changesThree monthsThe effect of depression as evaluated with Beck depression test on HbA1c changes and comparisons between the patient groups.
The effect of the level of physical activity on the HbA1c changesThree monthsThe effect of physical activity assessed by General practice physical activity questionnaire on HbA1c changes and comparisons between the patient groups.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026