Clinical trial NCT05394571: Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and HbA1c Changes With Therapy
Official title: Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and Early Changes in HbA1c Values With Tailored Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Poorly Controlled Diabetes Mellitus
Keywords: type 2 diabetes
poorly controlled Diabetes Mellitus
Lead sponsor: Goztepe Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been diagnosed with type 2 diabetes and have an HbA1c level equal to or higher than 10%

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in HbA1c levels after 3 months treatment
timeFrame: Three months
measure: Changes in HbA1c levels equal to or more than 20%
timeFrame: Three months
measure: ratio of patients who reached the HbA1c target of equal to or below 7%
timeFrame: Three months
Secondary outcomes:
measure: The effect of education on the HbA1c changes
timeFrame: Three months
measure: The effect of depression on the HbA1c changes
timeFrame: Three months
measure: The effect of the level of physical activity on the HbA1c changes
timeFrame: Three months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Study officials:
affiliation: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
name: Ayse N Erbakan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Satman I, Imamoglu S, Yilmaz C; ADMIRE Study Group. A patient-based study on the adherence of physicians to guidelines for the management of type 2 diabetes in Turkey. Diabetes Res Clin Pract. 2012 Oct;98(1):75-82. doi: 10.1016/j.diabres.2012.05.003. Epub 2012 May 29.