Clinical trial NCT05061459: The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy
Official title: The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Nephropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Expression levels of circANKRD36 in the development and progression of DN.
timeFrame: baseline
Secondary outcomes:
measure: Correlation between expression levels of circANKRD36 and pro-inflammatory cytokine (TNF-α and IL-6) in the development and progression of DN.
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References: