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Status unknownNCT05061459Updated Sep 29, 2021

The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy

An observational study in Diabetic Nephropathy, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2021-09-29.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
96
Sex
All
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Study 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.
Read the 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.

02

Conditions studied

  • Diabetic Nephropathy
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 96 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
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).

Inclusion criteria

  • Patients diagnosed as Type 2 Diabetes Mellitus

Exclusion criteria

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.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
96 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group1:

    28 control

    Genetic: circANKRD36 as a new biomarker

  • Group 2:

    68 T2DM patients

    Genetic: circANKRD36 as a new biomarker

Interventions

  • GeneticcircANKRD36 as a new biomarker

    expression levels of circANKRD36 in the development and progression of DN

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What researchers measure

Primary outcomes

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

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

    Time frame: baseline

Secondary outcomes

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

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

    Time frame: baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05061459
Lead sponsor
Assiut University
Responsible party
Marwa Magdy Hamed Mohamed (Doctor, Assiut University) — Principal investigator
First posted
Sep 29, 2021
Start date
Oct 2021 (estimated)
Primary completion
Oct 2023 (estimated)
Completion
Nov 2023 (estimated)
Last update
Sep 29, 2021

Study contacts

Marwa Magdy Hamed Mohamed, Assistant lecturer
Contact
marwamagdy@med.aun.edu.eg
01005745012
Heba Ahmed Abdel Hafeez, Prof. Dr.
Contact
dr_heba.ahmed@yahoo.com
01006268407

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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