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CompletedNCT06228898Updated Jan 29, 2024

Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes

An observational study in Poorly Controlled Diabetes Mellitus, sponsored by Goztepe Prof Dr Suleyman Yalcın City Hospital. Completed at 1 site in Turkey. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-29.

Sponsored by Goztepe Prof Dr Suleyman Yalcın City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
170
Ages
30 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 170 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Goztepe Prof Dr Suleyman Yalcın City Hospital is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
170 participants (actual)
Patient registry
No

Groups and cohorts

  • 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%.

06

What researchers measure

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.

    Time frame: three months

07

Study locations

1 site
  • Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06228898
Lead sponsor
Goztepe Prof Dr Suleyman Yalcın City Hospital
Responsible party
Ayse N Erbakan (Principal investigator, Goztepe Prof Dr Suleyman Yalcın City Hospital) — Principal investigator
First posted
Jan 29, 2024
Start date
Jan 15, 2022
Primary completion
Jan 15, 2023
Completion
Jan 15, 2023
Last update
Jan 29, 2024

Study contacts

Ayse N Erbakan, MD
principal investigator · Goztepe Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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