- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06067399
Relationship Between Red Cell Distribution Width (RDW) and HbA1C in Patients With Type 2 Diabetes Mellitus After Glycemic Control
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Asmaa N Hussein, MD
- Phone Number: 01065161752
- Email: asmaanady_1010@med.nvu.edu.eg
Study Locations
-
-
-
Kharga, Egypt
- Recruiting
- New Valley University- Faculty of Medicine
-
Contact:
- Asmaa Hussein, MD
- Phone Number: 01065161752
- Email: asmaanady_1010@med.nvu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients diagnosed to have Uncontrolled type 2 diabetes mellitus (HbA1C more than 7%)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Diabetics
|
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
|
2
Healthy control
|
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
Blood test will be done at time of recruitment (for 2 groups) , after 3 months and after 6 months (for group 1 )
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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"
|
"At time of inclusion in the study", "3 months", "6 months"
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine if changes in RDW levels correlate with the presence of other comorbidities and complications.
Time Frame: once
|
once
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Chrysarobin
Other Study ID Numbers
- T2DMRDW
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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