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

NCT06067399 | Recruiting

• 1 other identifier: T2DMRDW
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. DM has a number of associated complications, such as nephropathy, neuropathy, and cardiovascular disease.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

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

  once

Study Arms (2)

1

Diabetics

Diagnostic Test: Glycated hemoglobin (HbA1C); Diagnostic Test: RDW; Diagnostic Test: Lipid profile

2

Healthy control

Diagnostic Test: Glycated hemoglobin (HbA1C); Diagnostic Test: RDW; Diagnostic Test: Lipid profile

Interventions

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 )

1; 2

RDW DIAGNOSTIC_TEST

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

1; 2

Lipid profile DIAGNOSTIC_TEST

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

1; 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed to have type 2 diabetes

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Valley University: lead

Study Sites (1)

New Valley University- Faculty of Medicine

Al Khārjah, Egypt

RECRUITING

Related Publications (5)

• 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.

  PMID: 32843282 BACKGROUND

• 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.

  PMID: 34409130 BACKGROUND

• 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.

  PMID: 35561266 BACKGROUND

• 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.

  PMID: 31687307 BACKGROUND

• 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.

  PMID: 34125859 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Asmaa N Hussein, MD

CONTACT

01065161752; asmaanady_1010@med.nvu.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Internal Medicine and Clinical Hematology

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 4, 2023
• Study Start: December 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

EG (1)