Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes

NCT ID: NCT06228898

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-01-15

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.

Conditions

Poorly Controlled Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

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).

No interventions assigned to this group

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%.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Goztepe Prof Dr Suleyman Yalcın City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ayse N Erbakan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayse N Erbakan, MD

Role: PRINCIPAL_INVESTIGATOR

Goztepe Training and Research Hospital

Locations

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

hematological parameters-T2D

Identifier Type: -

Identifier Source: org_study_id