Conditions Associated With Poorly Controlled Diabetes in Patients With Type 2 Diabetes and HbA1c Changes With Therapy
NCT ID: NCT05394571
Last Updated: 2022-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
250 participants
OBSERVATIONAL
2021-08-15
2022-07-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Newly diagnosed diabetes
Patients who have been diagnosed with type 2 diabetes within a month
No interventions assigned to this group
Had controlled diabetes before
Patients who had at least two HbA1c levels =\<%7,5 before enrollment
No interventions assigned to this group
Had moderately uncontrolled diabetes
Patients who had at least two HbA1c levels between %7,5 and %9,49 before enrollment
No interventions assigned to this group
Had poorly controlled diabetes
Patients who had at least two HbA1c levels above %9,5 before enrollment
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* give consent to the study
* accessibility to the previous and recent test results
Exclusion Criteria
* acute metabolic decompensation
* unable to attend to the follow-ups
* having non-thyroid endocrine diseases
* active oncologic treatment
18 Years
80 Years
ALL
No
Sponsors
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Goztepe Training and Research Hospital
OTHER
Responsible Party
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Ayse N Erbakan
Principal Investigator
Principal Investigators
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Ayse N Erbakan, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Locations
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Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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Poorly controlled T2DM
Identifier Type: -
Identifier Source: org_study_id
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