Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes

Completed

• Conditions: Poorly Controlled Diabetes Mellitus

• Registration Number: NCT06228898
• Lead Sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2022-01-15
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Status Verified: 2024-01
• Study First Submitted: 2024-01-17
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
changes in hematologic inflammatory markers with glycemic control	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.

Trial Locations

Locations (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital; 🇹🇷 Istanbul, Turkey