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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-15

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Poorly Controlled Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Goztepe Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ayse N Erbakan

Principal Investigator

Responsibility Role 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)

Site Status

Countries

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Turkey (Türkiye)

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.

Reference Type BACKGROUND
PMID: 33298417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25287012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23665365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23407904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22652276 (View on PubMed)

Other Identifiers

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Poorly controlled T2DM

Identifier Type: -

Identifier Source: org_study_id

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