Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes

Poorly Controlled Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06228898
• Other study ID #: hematological parameters-T2D
• Status: Completed
• Start date: January 15, 2022
• Est. completion date: January 15, 2023

Study information

• Verified date: January 2024
• Source: Goztepe Prof Dr Suleyman Yalcin City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Poorly Controlled Diabetes Mellitus

Locations

Country	Name	City	State
Turkey	Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Goztepe Prof Dr Suleyman Yalcin City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in hematologic inflammatory markers with glycemic control	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