T-regulatory Cells in Diabetic Type Two Nephropathy

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03591939
Collaborator
(none)
63
14

Study Details

Study Description

Brief Summary

Diabetes mellitus is one of the most prevalent health problems worldwide. Diabetic nephropathy has become the leading cause of end-stage kidney disease worldwide and is associated with an increased cardiovascular risk.

Traditionally, metabolic and hemodynamic factors are the main causes of renal lesions in patients with type two diabetes mellitus and diabetic nephropathy , both considered non-immune diseases. Serial researches has demonstrated that diabetic nephropathy is a metabolic and hemodynamic disorder, with inflammation playing a vital role in the process.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: laboratory test

Detailed Description

It has been reported that glomerular basement membranes from diabetic rats induced significantly greater amounts of Tumor necrotic factor-alpha and Interleukin-1 than when these cells were incubated with basement membranes from non-diabetic rats.

These new findings were the first to suggest that inflammatory cytokines may participate in the pathogenesis of diabetic nephropathy .Cluster of differentiation 4 cells are believed to play central roles in modulating immune responses. Tumor necrotic factor-alpha and Interleukin-6, and induce inflammation in the pathogenesis of autoimmune diseases.

T- regulatory cells exert immunosuppressive effects which are important on the maintenance of immune homeostasis by producing anti-inflammatory cytokines, such as Interleukin-10 and transforming growth factor-b.

Aim of this work is to the role of T regulatory cells :( Cluster of differentiation 4, Cluster of differentiation 25,Cluster of differentiation 127 , forkhead box P3 cells) in the different stages of diabetic nephropathy before hemodialysis initiation.

Study Design

Study Type:
Observational
Anticipated Enrollment :
63 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Role of T-regulatory Cells in Type Two Diabetic Nephropathy
Anticipated Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
1

cases of Diabetic type two nephropathy

Diagnostic Test: laboratory test
role of T- regulatory cells in the patients of diabetic nephropathy

2

controls of normal subjects

Diagnostic Test: laboratory test
role of T- regulatory cells in the patients of diabetic nephropathy

Outcome Measures

Primary Outcome Measures

  1. rate of patients with positive T-regulatory cells in blood [one week]

    number of patients with diabetic type two nephropathy with positive T-regulatory cells in blood

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Adult patients above 20 years diagnosed with type 2 diabetes mellitus and have microalbuminuria, macroalbuminuria or renal impairment

Exclusion Criteria:

Patients with ischemic heart disease, any other autoimmune diseases, and Hepatitis C or B positive patients.

b-Patients with diabetic nephropathy on dialysis therapy c- Patients with any other causes for renal diseases such as glomerulonephritis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
HSGalal, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03591939
Other Study ID Numbers:
  • TRD
First Posted:
Jul 19, 2018
Last Update Posted:
Jul 19, 2018
Last Verified:
Jul 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 19, 2018