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

August 2, 2022 updated by: Ayse N Erbakan, Goztepe Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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%

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Newly diagnosed diabetes
Patients who have been diagnosed with type 2 diabetes within a month
Had controlled diabetes before
Patients who had at least two HbA1c levels =<%7,5 before enrollment
Had moderately uncontrolled diabetes
Patients who had at least two HbA1c levels between %7,5 and %9,49 before enrollment
Had poorly controlled diabetes
Patients who had at least two HbA1c levels above %9,5 before enrollment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in HbA1c levels after 3 months treatment
Time Frame: Three months
Changes in HbA1c levels after 3 months treatment according to the predetermined HbA1c groups.
Three months
Changes in HbA1c levels equal to or more than 20%
Time Frame: Three months
Comparison of the patient groups according to the reduction of 20% or more in HbA1c levels.
Three months
ratio of patients who reached the HbA1c target of equal to or below 7%
Time Frame: Three months
Comparison of the patient groups in their success in reaching the HbA1c target of equal to or below 7%.
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of education on the HbA1c changes
Time Frame: Three months
The effect of education on HbA1c changes and comparisons between the patient groups.
Three months
The effect of depression on the HbA1c changes
Time Frame: Three months
The effect of depression as evaluated with Beck depression test on HbA1c changes and comparisons between the patient groups.
Three months
The effect of the level of physical activity on the HbA1c changes
Time Frame: Three months
The effect of physical activity assessed by General practice physical activity questionnaire on HbA1c changes and comparisons between the patient groups.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Goztepe Training and Research Hospital

Investigators

  • Principal Investigator: Ayse N Erbakan, MD, Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2021

Primary Completion (Actual)

July 15, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

May 19, 2022

First Submitted That Met QC Criteria

May 23, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Poorly controlled T2DM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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