Poorly Controlled Diabetes MellitusNCT06228898
Changes in Hematological Parameters With Glycemia Control in Type 2 Diabetes
An observational study of Poorly Controlled Diabetes Mellitus, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Poorly Controlled Diabetes Mellitus
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2022to 15 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 18 years of age or older
- having type 2 diabetes
- giving consent to the study
- HbA1c level >=10 %
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul
About this study
Official title: Does the Hematological Inflammatory Parameters Differ When Glycemic Control is Achieved in Patients With Type 2 Diabetes
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.
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 Jan 2022
- Primary completion15 Jan 2023
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poorly Controlled Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse N Erbakan, Goztepe Prof Dr Suleyman Yalcın City Hospital
- Investigators
- Ayse N Erbakan, MD, Principal investigator, Goztepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228898
- Sponsor's protocol ID
- hematological parameters-T2D
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Hematological Inflammatory Parameters Differ When Glycemic Control is Achieved in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06228898
- Acronym / sponsor ID
- hematological parameters-T2D
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Goztepe Prof Dr Suleyman Yalcın City HospitalUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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%. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 18 years of age or older
- having type 2 diabetes
- giving consent to the study
- HbA1c level >=10 %
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes in hematologic inflammatory markers with glycemic control
Time frame: three months
to evaluate the potential alteration in hematologic inflammatory markers among patients with poorly controlled type 2 diabetes subsequent to the enhancement of diabetes management.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse N Erbakan, MD principal investigator
Goztepe Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poorly Controlled Diabetes Mellitus, run by Goztepe Prof Dr Suleyman Yalcın City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in hematologic inflammatory markers with glycemic control (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.