Diabetic Nephropathy Type 2 Clinical Trial
Official title:
Role of T-regulatory Cells in Type Two Diabetic Nephropathy
NCT number | NCT03591939 |
Other study ID # | TRD |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 1, 2018 |
Est. completion date | October 1, 2019 |
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.
Status | Not yet recruiting |
Enrollment | 63 |
Est. completion date | October 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Assiut University |
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. Review. — View 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. Erratum in: Clin Immunol. 2009 Dec;133(3):447. — View 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. — View Citation
Rivero A, Mora C, Muros M, García J, Herrera H, Navarro-González JF. Pathogenic perspectives for the role of inflammation in diabetic nephropathy. Clin Sci (Lond). 2009 Mar;116(6):479-92. doi: 10.1042/CS20080394. Review. — View 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. Review. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of patients with positive T-regulatory cells in blood | number of patients with diabetic type two nephropathy with positive T-regulatory cells in blood | one week |
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