The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy

Diabetic Nephropathy Clinical Trial

Official title:

The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05061459
• Other study ID #: The expression of circANKRD36
• Status: Not yet recruiting
• Start date: October 2021
• Est. completion date: November 2023

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: Marwa Magdy Hamed Mohamed, Assistant lecturer
• Phone: 01005745012
• Email: marwamagdy[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

1. To evaluate expression levels of circANKRD36 in the development and progression of DN.

2. To investigate correlation between expression levels of circANKRD36 and stages of DN.

3. To investigate correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in T2DM patients with CKD.

Description:

Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic disorders that's become a global health burden affecting 463 million people worldwide according to the International Diabetes Federation (IDF). Diabetic nephropathy(DN) is one of the most common secondary complications of DM and is becoming a major cause of morbidity and mortality among diabetic patients . DN is a microvascular complication occurring in approximately 20-40% of patients with T2DM . DN has been described as a glomerular disorder with the following phases: glomerular hyperfiltration, incipient nephropathy, microalbuminuria, overt proteinuria and end-stage renal disorder. Microalbuminuria is the gold standard for the early diagnosis of DN. However, many studies have suggested that it is inadequate and has some drawbacks. Recent novel biomarkers have been accepted for early diagnosis and progression of DN in patients with T2DM . Renal cells are capable of synthesizing pro-inflammatory cytokines such as tumor necrotic factor-alpha (TNF-α), interleukin-1β (IL-1β) and interleukin-6 (IL-6), these cytokines acting in a paracrine or autocrine manner that leading to the development and progression of several renal disorders .Circular RNAs are class of endogenous non coding RNAs and are associated with numerous diseases like T2DM. Circular ankyrin repeat domain 36 (circANKRD36) involved in T2DM and inflammation-associated pathways via interaction with miRNAs, including hsa-miR-3614-3p, hsa-miR-498, and hsa-miR-501-5p. The expression of circANKRD36 was upregulated in peripheral blood leucocytes and was correlated with chronic inflammation in T2DM. Therefore, circANKRD36 can be used as a potential biomarker for screening chronic inflammation in patients with T2DM.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed as Type 2 Diabetes Mellitus

Exclusion Criteria:

• Any other clinically systemic acute or chronic inflammation disease/s.

• Autoimmune disease.

• Any endocrine disease other than T2DM.

• Cancer.

• Chronic hepatic or renal failure.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Genetic:
• circANKRD36 as a new biomarker
expression levels of circANKRD36 in the development and progression of DN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression levels of circANKRD36 in the development and progression of DN.	circANKRD36 by reverse transcription-quantitative polymerase chain reaction (RT-qPCR)	baseline
Secondary	Correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-a and IL-6) in the development and progression of DN.	pro-inflammatory cytokine TNF-a by enzyme-linked immunosorbent assay (ELISA). IL-6 by Chemiluminescence on Advia centaur XPT.	baseline