The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy

September 28, 2021 updated by: Marwa Magdy Hamed Mohamed, Assiut University

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

  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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study will include 96 (68 patients diagnosed as T2DM and 28 apparently healthy subjects as control group).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1:
28 control
Genetic: circANKRD36 as a new biomarker
expression levels of circANKRD36 in the development and progression of DN
Group 2:
68 T2DM patients
Genetic: circANKRD36 as a new biomarker
expression levels of circANKRD36 in the development and progression of DN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression levels of circANKRD36 in the development and progression of DN.
Time Frame: baseline
circANKRD36 by reverse transcription-quantitative polymerase chain reaction (RT-qPCR)
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in the development and progression of DN.
Time Frame: baseline
pro-inflammatory cytokine TNF-α by enzyme-linked immunosorbent assay (ELISA). IL-6 by Chemiluminescence on Advia centaur XPT.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The expression of circANKRD36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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