Irisin Hormone as a Novel Diagnostic Marker for Detection... | NCT07435480

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

NCT07435480

Sponsor

Sohag University

Status

Not yet recruiting

Last Update Posted

Mar 10, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Diabetic Nephropathies

Interventions

HBa1c
glucose

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2026Estimated

Primary Completion Date

Mar 1, 2027Estimated

Completion Date

Mar 1, 2028Estimated

First Submitted Date

Feb 20, 2026

First Submission Date that Met QC Criteria

Feb 20, 2026

First Posted Date

Feb 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2026

Last Update Posted Date

Mar 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HBa1c	Diagnostic Test	Rapid method for detection of diabetes
glucose	Diagnostic Test	accurate method for diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 ).	Two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Type 2 diabetic patients between 30-75 years old

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gehad Ha Abdelmegid, MD	Contact	00201125745717		gege1_8_1992@yahoo.com

Overall Officials

Name	Affiliation	Role
Ahmed Se Mahmoud, ass prof	Sohag University	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided