NCT03591939

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1 year

First QC Date

July 8, 2018

Last Update Submit

July 8, 2018

Conditions

Diabetic Nephropathy Type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

cases of Diabetic type two nephropathy

Diagnostic Test: laboratory test

2

controls of normal subjects

Diagnostic Test: laboratory test

Interventions

laboratory testDIAGNOSTIC_TEST

role of T- regulatory cells in the patients of diabetic nephropathy

12

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 15606719BACKGROUND

  • 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.

    PMID: 19200057BACKGROUND

  • 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.

    PMID: 1762301BACKGROUND

  • 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.

    PMID: 15229474BACKGROUND

  • 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.

    PMID: 18294918BACKGROUND

  • 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.

    PMID: 16903903BACKGROUND

MeSH Terms

Interventions

Clinical Laboratory Techniques

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Muhammed Hossam Maghraby, professor

CONTACT

00201020671222hossammaghraby@med.au.edu.eg

Walaa Hosny Hosny Muhammed, lecturer

CONTACT

00201005220944walaa.hosny2012@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 8, 2018

First Posted

July 19, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share