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Type 2 DiabetesNCT06067399

Relationship Between Red Cell Distribution Width (RDW) and HbA1C in Patients With Type 2 Diabetes Mellitus After Glycemic Control

An observational study of Type 2 Diabetes, run by New Valley University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Diabetes mellitus (DM) is an epidemic disease, with approximately 463 million persons diagnosed with it. Of those, 90% are patients with type 2 DM (T2DM). Some estimates indicate that 700 million cases of DM will be reported in 2045. T2DM develops due to insulin resistance, leading to reduced insulin secretion. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
Glycated hemoglobin (HbA1C), RDW and Lipid profile
How many people
250 participants
Where
1 siteEgypt
Study dates
1 May 2026to 30 Jun 2028
Phase
Observational
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients diagnosed to have type 2 diabetes

Who may be able to join

  • Patients diagnosed to have Uncontrolled type 2 diabetes mellitus (HbA1C more than 7%)

Who cannot join

  • Patients diagnosed to have type 1 diabetes.
  • Patients are diagnosed to have secondary diabetes.
  • Clinical states associated with increased RDW:
  • Anemia (Female Hb less than 12, Male Hb less than 13) either due to hemolysis, or in response to ineffective red cell production, which can be caused by deficiencies in iron, vitamin B12 or folate.
  • After blood transfusions
  • Pregnancy, thrombotic thrombocytopenic purpura and inflammatory bowel disease.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Asmaa N Hussein, MD contact

01065161752

asmaanady_1010@med.nvu.edu.eg

Egypt1 site, 1 recruiting

  • New Valley University- Faculty of Medicine

    Al Khārjah

    Asmaa Hussein, MD, 01065161752, asmaanady_1010@med.nvu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Diabetes mellitus (DM) is an epidemic disease, with approximately 463 million persons diagnosed with it. Of those, 90% are patients with type 2 DM (T2DM). Some estimates indicate that 700 million cases of DM will be reported in 2045. T2DM develops due to insulin resistance, leading to reduced insulin secretion. DM has a number of associated complications, such as nephropathy, neuropathy, and cardiovascular disease.

Read the detailed description

The health status of normal individuals and patients with various diseases is commonly monitored using the complete blood count (CBC). In patients with T2DM, the CBC can be used as a follow-up test, which will help in reducing complications associated with the disease. Some CBC parameters have also been used as prognostic markers for T2DM. One of these markers is the red cell distribution width (RDW), which measures the variability in the sizes of red blood cells (RBCs) and is considered an indicator of their heterogeneity. The evidence associating RDW with a higher risk of mortality has been expanding since the initial report of its prognostic utility in heart failure patients. Multiple studies have shown that elevated RDW values are associated with many human diseases, such as cancer, cardiovascular disease, and diabetes, and are also associated with disease activity or complications of diseases. The RDW can be used diagnostically in patients with T2DM and other illnesses, as patients with T2DM frequently show alterations in various hematological properties, including changes in the structure, metabolism, and function of blood cells. These alterations can be caused by different factors, such as excessive levels of reactive oxygen species (ROS), leading eventually to oxidative stress and the dysfunction of RBCs.

The relationship between RDW and T2DM has been studied for several years, and there are no consistent results.

Conditions
Type 2 Diabetes
Being tested
Glycated hemoglobin (HbA1C), RDW, Lipid profile
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.

  • Glycated hemoglobin (HbA1C)Diagnostic test

    Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )

  • RDWDiagnostic test

    Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )

  • Lipid profileDiagnostic test

    Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )

Study groups in NCT06067399
Study groupRoleWhat they receive
1Diabetics
Receives: Diagnostic Test: Glycated hemoglobin (HbA1C); Diagnostic Test: RDW; Diagnostic Test: Lipid profile
2Healthy control
Receives: Diagnostic Test: Glycated hemoglobin (HbA1C); Diagnostic Test: RDW; Diagnostic Test: Lipid profile

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the correlation between RDW and HbA1C levels in patients with T2DM before and after glycemic control.

    Measured: "At time of inclusion in the study", "3 months", "6 months"

Secondary outcomes (1)

  1. To determine if changes in RDW levels correlate with the presence of other comorbidities and complications.

    Measured: once

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start1 May 2026
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
Case-control
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067399
Sponsor's protocol ID
T2DMRDW
Status last verified
Jul 2026
First submitted
21 Sep 2023
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Valtierra-Alvarado MA, Castaneda Delgado JE, Ramirez-Talavera SI, Lugo-Villarino G, Duenas-Arteaga F, Lugo-Sanchez A, Adame-Villalpando MS, Rivas-Santiago B, Enciso-Moreno J, Serrano CJ. Type 2 diabetes mellitus metabolic control correlates with the phenotype of human monocytes and monocyte-derived macrophages. J Diabetes Complications. 2020 Nov;34(11):107708. doi: 10.1016/j.jdiacomp.2020.107708. Epub 2020 Aug 13.

    PubMed 32843282

  • Ooi TC, Mat Ludin AF, Loke SC, Fiatarone Singh MA, Wong TW, Vytialingam N, Anthony Abdullah MMJ, Ng OC, Bahar N, Zainudin N, Lew LC. A 16-Week Home-Based Progressive Resistance Tube Training Among Older Adults With Type-2 Diabetes Mellitus: Effect on Glycemic Control. Gerontol Geriatr Med. 2021 Aug 12;7:23337214211038789. doi: 10.1177/23337214211038789. eCollection 2021 Jan-Dec.

    PubMed 34409130

  • Nah EH, Cho S, Park H, Kim S, Cho HI. Associations of complete blood count parameters with pancreatic beta-cell function and insulin resistance in prediabetes and type 2 diabetes mellitus. J Clin Lab Anal. 2022 Jun;36(6):e24454. doi: 10.1002/jcla.24454. Epub 2022 May 13.

    PubMed 35561266

  • Bhutto AR, Abbasi A, Abro AH. Correlation of Hemoglobin A1c with Red Cell Width Distribution and Other Parameters of Red Blood Cells in Type II Diabetes Mellitus. Cureus. 2019 Aug 30;11(8):e5533. doi: 10.7759/cureus.5533.

    PubMed 31687307

  • Arkew M, Yemane T, Mengistu Y, Gemechu K, Tesfaye G. Hematological parameters of type 2 diabetic adult patients at Debre Berhan Referral Hospital, Northeast Ethiopia: A comparative cross-sectional study. PLoS One. 2021 Jun 14;16(6):e0253286. doi: 10.1371/journal.pone.0253286. eCollection 2021.

    PubMed 34125859

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes, run by New Valley University at 1 site in Egypt.

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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 30 Jul 2026. 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 Egypt. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Asmaa N Hussein, MD (01065161752, asmaanady_1010@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the correlation between RDW and HbA1C levels in patients with T2DM before and after glycemic control. (time frame: "At time of inclusion in the study", "3 months", "6 months"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06067399, which also lists 5 linked publications.

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 30 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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