The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05061459
Collaborator
(none)
96
25

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: circANKRD36 as a new biomarker

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 Design

Study Type:
Observational
Anticipated Enrollment :
96 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Expression levels of circANKRD36 in the development and progression of DN. [baseline]

    circANKRD36 by reverse transcription-quantitative polymerase chain reaction (RT-qPCR)

Secondary Outcome Measures

  1. Correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in the development and progression of DN. [baseline]

    pro-inflammatory cytokine TNF-α by enzyme-linked immunosorbent assay (ELISA). IL-6 by Chemiluminescence on Advia centaur XPT.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marwa Magdy Hamed Mohamed, Doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT05061459
Other Study ID Numbers:
  • The expression of circANKRD36
First Posted:
Sep 29, 2021
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2021