Clinical trial NCT03591939: T-regulatory Cells in Diabetic Type Two Nephropathy
Official title: Role of T-regulatory Cells in Type Two Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Nephropathy Type 2
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 63
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects will be collected in a questionnaire form; from outpatient clinic in Assiut University hospital .These will be included in a file sheet for each subject : Age, Sex, Body height, weight and body mass index,Special habits ,fundus examination and neurological examination ,Blood pressure, pulse ,General and systematic examination Investigations will include; urine analysis, blood urea and serum creatinine, complete blood count, Fasting and 2 h post pranidal glucose levels

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: rate of patients with positive T-regulatory cells in blood
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wolf G. New insights into the pathophysiology of diabetic nephropathy: from haemodynamics to molecular pathology. Eur J Clin Invest. 2004 Dec;34(12):785-96. doi: 10.1111/j.1365-2362.2004.01429.x.
citation: Rivero A, Mora C, Muros M, Garcia J, Herrera H, Navarro-Gonzalez JF. Pathogenic perspectives for the role of inflammation in diabetic nephropathy. Clin Sci (Lond). 2009 Mar;116(6):479-92. doi: 10.1042/CS20080394.
citation: Hasegawa G, Nakano K, Sawada M, Uno K, Shibayama Y, Ienaga K, Kondo M. Possible role of tumor necrosis factor and interleukin-1 in the development of diabetic nephropathy. Kidney Int. 1991 Dec;40(6):1007-12. doi: 10.1038/ki.1991.308.
citation: Adkins B, Leclerc C, Marshall-Clarke S. Neonatal adaptive immunity comes of age. Nat Rev Immunol. 2004 Jul;4(7):553-64. doi: 10.1038/nri1394. No abstract available.
citation: Cheng X, Yu X, Ding YJ, Fu QQ, Xie JJ, Tang TT, Yao R, Chen Y, Liao YH. The Th17/Treg imbalance in patients with acute coronary syndrome. Clin Immunol. 2008 Apr;127(1):89-97. doi: 10.1016/j.clim.2008.01.009. Epub 2008 Feb 21.
citation: Sakaguchi S, Ono M, Setoguchi R, Yagi H, Hori S, Fehervari Z, Shimizu J, Takahashi T, Nomura T. Foxp3+ CD25+ CD4+ natural regulatory T cells in dominant self-tolerance and autoimmune disease. Immunol Rev. 2006 Aug;212:8-27. doi: 10.1111/j.0105-2896.2006.00427.x.