Diabetic NephropathiesNCT07435480
Irisin Hormone as a Novel Diagnostic Marker for Detection and Progression of Diabetic Nephrophathy Patients
An observational study of Diabetic Nephropathies, run by Sohag University.
Trial summary
Study the relation between irisin level and progression of diabetic nephropathy and its early detection. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetic Nephropathies
- What is being tested?
- HBa1c and glucose
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Mar 2028
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 75 years
- All sexes
- Adult, Older adult
Study population: Type 2 diabetic patients between 30-75 years old
Who may be able to join
- Type 2 diabetic patients
Who cannot join
- Non-diabetic kidney diseases.
- Acute illness, infection, obesity, hypertension, type 1 DM.
- Malignancy, other endocrine disorders, corticosteroid drugs, pregnancy, lactation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Irisin as a Novel Diagnostic Marker for Early Detection and Progression of Diabetic Nephrophathy
Study the relation between irisin level and progression of diabetic nephropathy and its early detection.
Read the detailed description
Diabetes is a prevalent worldwide challenge affecting 425 million individuals, with the International Diabetes Federation (IDF) projecting a rise to 630 million by 2045. Diabetic nephropathy (DN) is a critical complication that impacts one-third of diabetic patients and significantly contributes to cardiovascular morbidity and mortality, leading to substantial socioeconomic burdens (Dwivedi and Sikarwar, 2024).
Diabetic nephropathy (DN) is a multifaceted condition involving various interconnected mechanisms, primarily influenced by hyperglycemia .
Diabetic nephropathy (DN) is one of the most feared diabetic chronic microvascular complications and the major cause of end-stage renal disease (ESRD).
Therefore, early recognition is crucial. Presently, this relies on the albumin excretion rate (AER) and glomerular filtration rate (GFR).
Irisin, an exercise - induced myokine, has been linked to metabolic disorders, but its relationship with DN remains unclear.
Experimental studies have demonstrated the role of irisin in protecting mice against diabetes and obesity
- Conditions
- Diabetic Nephropathies
- Being tested
- HBa1c, glucose
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBa1cDiagnostic test
Rapid method for detection of diabetes
glucoseDiagnostic test
accurate method for diabetes
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure number of Participants With Diabetic nephropathy Adverse healthy people as Assessed by irisin hormone ).
Participants With Diabetic nephropathy Adverse healthy people as Assessed by irisin hormone ).
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Sohag 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehad Hamdy Abdelmegid, Sohag University
- Investigators
- Ahmed Se Mahmoud, ass prof, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435480
- Sponsor's protocol ID
- Soh-Med--26-2-1MD
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Irisin as a Novel Diagnostic Marker for Early Detection and Progression of Diabetic Nephrophathy
- ClinicalTrials.gov ID
- NCT07435480
- Acronym / sponsor ID
- Soh-Med--26-2-1MD
- Conditions
- Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 27 Feb 2026 (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.
Study the relation between irisin level and progression of diabetic nephropathy and its early detection.
Detailed description
Diabetes is a prevalent worldwide challenge affecting 425 million individuals, with the International Diabetes Federation (IDF) projecting a rise to 630 million by 2045. Diabetic nephropathy (DN) is a critical complication that impacts one-third of diabetic patients and significantly contributes to cardiovascular morbidity and mortality, leading to substantial socioeconomic burdens (Dwivedi and Sikarwar, 2024).
Diabetic nephropathy (DN) is a multifaceted condition involving various interconnected mechanisms, primarily influenced by hyperglycemia .
Diabetic nephropathy (DN) is one of the most feared diabetic chronic microvascular complications and the major cause of end-stage renal disease (ESRD).
Therefore, early recognition is crucial. Presently, this relies on the albumin excretion rate (AER) and glomerular filtration rate (GFR).
Irisin, an exercise - induced myokine, has been linked to metabolic disorders, but its relationship with DN remains unclear.
Experimental studies have demonstrated the role of irisin in protecting mice against diabetes and obesity
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic patients between 30-75 years old
Key inclusion criteria (1 listed)
- Type 2 diabetic patients
Key exclusion criteria (3 listed)
- Non-diabetic kidney diseases.
- Acute illness, infection, obesity, hypertension, type 1 DM.
- Malignancy, other endocrine disorders, corticosteroid drugs, pregnancy, lactation.
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 |
|---|---|---|
| HBa1cRapid method for detection of diabetes | Diagnostic test | – |
| glucoseaccurate method for diabetes | Diagnostic test | – |
Primary outcome
Measure number of Participants With Diabetic nephropathy Adverse healthy people as Assessed by irisin hormone ).
Time frame: Two years
Participants With Diabetic nephropathy Adverse healthy people as Assessed by irisin hormone ).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Ahmed Se Mahmoud, ass prof study director
Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies, run by Sohag 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 3 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: opening soon, as of the sponsor's last update on 10 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gehad Ha Abdelmegid, MD (00201125745717, gege1_8_1992@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure number of Participants With Diabetic nephropathy Adverse healthy people as Assessed by irisin hormone ). (time frame: Two years). 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 10 Mar 2026.