Clinical trial NCT06228898: Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes
Official title: Does the Hematological Inflammatory Parameters Differ When Glycemic Control is Achieved in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Poorly Controlled Diabetes Mellitus
Keywords: type 2 diabetes
glycemic control
neutrophils
neutrophil/lymphocyte ratio
lymphocyte/monocyte ratio
platelet/lymphocyte ratio
monocytes/HDL-cholesterol ratio
platelets/HDL ratio
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 170
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: changes in hematologic inflammatory markers with glycemic control
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Study officials:
affiliation: Goztepe Training and Research Hospital
name: Ayse N Erbakan, MD
role: PRINCIPAL_INVESTIGATOR
References: