Diabetic NephropathyNCT05061459
The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy
An observational study of Diabetic Nephropathy, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- circANKRD36 as a new biomarker
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study will include 96 (68 patients diagnosed as T2DM and 28 apparently healthy subjects as control group).
Who may be able to join
- Patients diagnosed as Type 2 Diabetes Mellitus
Who cannot join
- Any other clinically systemic acute or chronic inflammation disease/s.
- Autoimmune disease.
- Any endocrine disease other than T2DM.
- Cancer.
- Chronic hepatic or renal failure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus
- To evaluate expression levels of circANKRD36 in the development and progression of DN.
- To investigate correlation between expression levels of circANKRD36 and stages of DN.
- 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.
- Conditions
- Diabetic Nephropathy
- Being tested
- circANKRD36 as a new biomarker
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
circANKRD36 as a new biomarkerGenetic
expression levels of circANKRD36 in the development and progression of DN
| Study group | Role | What they receive |
|---|---|---|
| Group1: | 28 control Receives: Genetic: circANKRD36 as a new biomarker | |
| Group 2: | 68 T2DM patients Receives: Genetic: circANKRD36 as a new biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels of circANKRD36 in the development and progression of DN.
circANKRD36 by reverse transcription-quantitative polymerase chain reaction (RT-qPCR)
Measured: 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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Magdy Hamed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061459
- Sponsor's protocol ID
- The expression of circANKRD36
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expression of circANKRD36 as a New Biomarker of Diabetic Nephropathy in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05061459
- Acronym / sponsor ID
- The expression of circANKRD36
- Conditions
- Diabetic Nephropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To evaluate expression levels of circANKRD36 in the development and progression of DN.
- To investigate correlation between expression levels of circANKRD36 and stages of DN.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group1: | – | Genetic: circANKRD36 as a new biomarker28 control |
| Group 2: | – | Genetic: circANKRD36 as a new biomarker68 T2DM patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include 96 (68 patients diagnosed as T2DM and 28 apparently healthy subjects as control group).
Key inclusion criteria (1 listed)
- Patients diagnosed as Type 2 Diabetes Mellitus
Key exclusion criteria (5 listed)
- Any other clinically systemic acute or chronic inflammation disease/s.
- Autoimmune disease.
- Any endocrine disease other than T2DM.
- Cancer.
- Chronic hepatic or renal failure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| circANKRD36 as a new biomarkerexpression levels of circANKRD36 in the development and progression of DN | Genetic | Group 2:, Group1: |
Primary outcome
Expression levels of circANKRD36 in the development and progression of DN.
Time frame: baseline
circANKRD36 by reverse transcription-quantitative polymerase chain reaction (RT-qPCR)
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathy, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa Magdy Hamed Mohamed, Assistant lecturer (01005745012, marwamagdy@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of circANKRD36 in the development and progression of DN. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.