Irisin Hormone as a Novel Diagnostic Marker for Detection and Progression of Diabetic Nephrophathy Patients

March 7, 2026 updated by: Gehad Hamdy Abdelmegid, Sohag University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Type 2 diabetic patients between 30-75 years old

Description

Inclusion Criteria:

Type 2 diabetic patients

Exclusion Criteria:

  • Non-diabetic kidney diseases.
  • Acute illness, infection, obesity, hypertension, type 1 DM.
  • Malignancy, other endocrine disorders, corticosteroid drugs, pregnancy, lactation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 ).
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Investigators

  • Study Director: Ahmed Se Mahmoud, ass prof, Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1-Deng, Y., Shen, Y., Wu, Y., Wen, M., and Wang, F. (2025). Correlation of serum irisin levels with diabetic nephropathy: an exhaustive systematic appraisal and meta-analytical investigation. Frontiers in Endocrinology, 16, 1599423. 2- Dwivedi, S., and Sikarwar, M. S. (2024). Diabetic nephropathy: pathogenesis, mechanisms, and therapeutic strategies. Hormone and Metabolic Research. 3 - Mageswari, R., Sridhar, M. G., Nandeesha, H., Parameshwaran, S., and Vinod, K. V. (2019). Irisin and visfatin predicts severity of diabetic nephropathy. Indian Journal of Clinical Biochemistry, 34(3), 342-346. 4- Satta, E., Strollo, F., Borgia, L., Guarino, G., Romano, C., Masarone, M., Marfella, R., and Gentile, S. (2025). Urinary L-FABP: A Novel Biomarker for Evaluating Diabetic Nephropathy Onset and Progression. A Narrative Review. Diabetes Therapy, 1-18. 5-Yuan, C. M., Nee, R., Ceckowski, K. A., Knight, K. R., & Abbott, K. C. (2017). Diabetic nephropathy as the cause of end-stage kidney disease reported on the medical evidence form CMS2728 at a single center. Clinical kidney journal, 10(2), 257-262. 6-Zhang, X., Zhang, J., Ren, Y., Sun, R., & Zhai, X. (2024). Unveiling the pathogenesis and therapeutic approaches for diabetic nephropathy: insights from panvascular diseases. Frontiers in endocrinology, 15, 1368481.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 20, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--26-2-1MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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