Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes

January 26, 2024 updated by: Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital

Does the Hematological Inflammatory Parameters Differ When Glycemic Control is Achieved in Patients With Type 2 Diabetes

There is a systemic low-grade chronic inflammation in diabetes, and research suggests that this inflammation plays a vital role in the development of diabetic complications. Macrovascular complications, which are associated with atherosclerosis, are recognized as a chronic inflammatory disease. In this study, the aim was to evaluate the potential alteration in hematologic inflammatory markers among patients with poorly controlled type 2 diabetes subsequent to the enhancement of diabetes management.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients who were referred to the Diabetes Outpatient Clinics and had HbA1c levels equal to or greater than 10% were enrolled in this study. Detailed medical histories, comorbidities and medication usage (including both regular and new prescriptions), adherence to dietary recommendations, and occurence of recent infections were collected. Additionally, the patients' biochemical and hematological data were collected. After a three-month period, follow-up interviews with the same patients were conducted to inquire about any changes in medication usage, experienced illnesses, and hospital admissions. Based on the changes in HbA1c levels during this three-month period, the patients were divided into three equal groups. The baseline and third-month leukocyte counts, neutrophil counts, lymphocyte counts, and platelet counts for these groups were recorded. Furthermore, the neutrophil/lymphocyte ratio, lymphocyte/monocyte ratio, platelet/lymphocyte ratio, monocytes/HDL-cholesterol ratio, and platelets/HDL ratio for each group were analyzed.

Study Type

Observational

Enrollment (Actual)

170

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with poorly controlled type 2 diabetes, defined by an HbA1c level of >=10%, who attended diabetes outpatient clinics between January 2022 and January 2023.

Description

Inclusion Criteria:

  • 18 years of age or older
  • having type 2 diabetes
  • giving consent to the study
  • HbA1c level >=10 %

Exclusion Criteria:

  • presence of acute infection
  • presence of other diseases that can cause inflammation
  • hematological diseases
  • acute metabolic decompensation
  • not being able to come to follow-ups
  • presence of non-thyroid endocrine disease
  • application of oncologic treatment
  • leukocyte count >12 000

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

Cohorts and Interventions

Group / Cohort
patients with type 2 diabetes with improved HbA1c
Participants with type 2 diabetes with a reduction in HbA1c ranging from 5% to 11.6% in three months time (n=56)
patients with type 2 diabetes with a better HbA1c
Group 2 comprised individuals with type 2 diabetes who exhibited a decline in HbA1c levels ranging from 2.8% to 4.9% in three months time (n=56).
patients with type 2 diabetes with little or no HbA1c change
Group 3 comprised 58 participants who exhibited a decrease in HbA1c levels ranging from 2.7% to 0%, in addition to an increase ranging from 0.1% to 3.4%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in hematologic inflammatory markers with glycemic control
Time Frame: three months
to evaluate the potential alteration in hematologic inflammatory markers among patients with poorly controlled type 2 diabetes subsequent to the enhancement of diabetes management.
three months

Collaborators and Investigators

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

Sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital

Investigators

  • Principal Investigator: Ayse N Erbakan, MD, Goztepe Training and Research Hospital

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)

January 15, 2022

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

January 15, 2023

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hematological parameters-T2D

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

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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