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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05394571
• Other study ID #: Poorly controlled T2DM
• Status: Completed
• Start date: August 15, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: Goztepe Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: July 30, 2022
• Est. primary completion date: July 15, 2022
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Poorly Controlled Diabetes Mellitus
• Type 2 Diabetes

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

American Diabetes Association. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. doi: 10.2337/dc21-S006. Review. — View Citation

Nichols GA, Joshua-Gotlib S, Parasuraman S. Glycemic control and risk of cardiovascular disease hospitalization and all-cause mortality. J Am Coll Cardiol. 2013 Jul 9;62(2):121-127. doi: 10.1016/j.jacc.2013.04.031. Epub 2013 May 9. — View 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. — View Citation

Satman I, Omer B, Tutuncu Y, Kalaca S, Gedik S, Dinccag N, Karsidag K, Genc S, Telci A, Canbaz B, Turker F, Yilmaz T, Cakir B, Tuomilehto J; TURDEP-II Study Group. Twelve-year trends in the prevalence and risk factors of diabetes and prediabetes in Turkish adults. Eur J Epidemiol. 2013 Feb;28(2):169-80. doi: 10.1007/s10654-013-9771-5. Epub 2013 Feb 14. — View Citation

Walraven I, Mast MR, Hoekstra T, Jansen AP, van der Heijden AA, Rauh SP, Rutters F, van 't Riet E, Elders PJ, Moll AC, Polak BC, Dekker JM, Nijpels G. Distinct HbA1c trajectories in a type 2 diabetes cohort. Acta Diabetol. 2015 Apr;52(2):267-75. doi: 10.1007/s00592-014-0633-8. Epub 2014 Oct 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in HbA1c levels after 3 months treatment	Changes in HbA1c levels after 3 months treatment according to the predetermined HbA1c groups.	Three months
Primary	Changes in HbA1c levels equal to or more than 20%	Comparison of the patient groups according to the reduction of 20% or more in HbA1c levels.	Three months
Primary	ratio 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%.	Three months
Secondary	The effect of education on the HbA1c changes	The effect of education on HbA1c changes and comparisons between the patient groups.	Three months
Secondary	The effect of depression on the HbA1c changes	The effect of depression as evaluated with Beck depression test on HbA1c changes and comparisons between the patient groups.	Three months
Secondary	The effect of the level of physical activity on the HbA1c changes	The effect of physical activity assessed by General practice physical activity questionnaire on HbA1c changes and comparisons between the patient groups.	Three months