The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy

NCT ID: NCT05061459

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-31

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetic Nephropathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group1:

28 control

circANKRD36 as a new biomarker

Intervention Type GENETIC

expression levels of circANKRD36 in the development and progression of DN

Group 2:

68 T2DM patients

circANKRD36 as a new biomarker

Intervention Type GENETIC

expression levels of circANKRD36 in the development and progression of DN

Interventions

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circANKRD36 as a new biomarker

expression levels of circANKRD36 in the development and progression of DN

Intervention Type GENETIC

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Magdy Hamed Mohamed

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Marwa Magdy Hamed Mohamed, Assistant lecturer

Role: CONTACT

01005745012

Heba Ahmed Abdel Hafeez, Prof. Dr.

Role: CONTACT

01006268407

Other Identifiers

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The expression of circANKRD36

Identifier Type: -

Identifier Source: org_study_id

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