Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes

NCT06228898 | Completed

• 1 other identifier: hematological parameters-T2D
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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%.

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Goztepe Prof Dr Suleyman Yalcın City Hospital: lead

Study Sites (1)

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ayse N Erbakan, MD

  Goztepe Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 29, 2024
• Study Start: January 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)