Diabetic kidney disease is histopathologically characterized by several alterations in the kidney, such as nodular glomerulosclerosis, mesangial enlargement, cellar membrane thickener and interstitial fibrosis. Clinically, diabetic kidney disease is normally a configuration of relentless proteinurias, elevated arterial blood force per unit area and diminution in kidney map [ 13 ] .

Phase I: Hypertrophic hyper filtration. In this phase, GFR is either normal or increased. Phase I lasts about five old ages from the oncoming of the disease. The size of the kidneys is increased by about 20 % and nephritic plasma flow is increased by 10 % -15 % , while proteinurias and blood force per unit area remain within the normal scope.

Phase Two: The quiet phase. This phase starts about two old ages after the oncoming of the disease and is characterized by kidney harm with cellar membrane thickener and mesangial proliferation. There are still no clinical marks of the disease. GFR returns to normal values. Many patients remain in this phase until the terminal of their life.

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Phase Three: The microalbuminuria phase ( albumin 30-300 mg/dU ) or initial nephropathy. This is the first clinically noticeable mark of glomerular harm. It normally occurs five to ten old ages after the oncoming of the disease. Blood force per unit area may be increased or normal. Approximately 40 % of patients reach this phase.

Phase Four: Chronic kidney failure ( CKF ) is the irreversible phase. Proteinuria develops ( albumin & gt ; 300 mg/dU ) , GFR decreases below 60 mL/min/1.73 M2, and blood force per unit area additions above normal values.

Phase V: Terminal kidney failure ( TKF ) ( GFR & lt ; 15 mL/min/1.73 M2 ) . Approximately 50 % of the patients with TKF require kidney replacing therapy ( peritoneal dialysis, haemodialysis, kidney organ transplant ) [ 5 ] .

In the initial phases of diabetic nephropathy, increased kidney size and changed Doppler indexs may be the early morphological marks of nephritic harm, while albuminurias and GFR are the best indexs of the grade of the harm [ 6 ] .Changes in proteinurias are considered a trademark of oncoming or patterned advance of nephropathy. .

Study Setting: The topics will be required at outpatient ‘s clinic of nephropathy, University Diabetes Center, King Abdul Aziz University Hospital, King Saud University, Riyadh. All laboratory work will be performed at Strategic Centre for Diabetic Research, King Saud University.

Study Design:

The case-control surveies will necessitate 586 topics for this survey. The 600 samples will be recruited harmonizing to the Raosoft, the mistake border of the group will give 5 % and 95 % ( CI ) assurance degree. The group will be dived in different phases of disease patterned advance.

Study topics will be recruited from the out-patient section at University Diabetes Center, King Saud University. The indiscriminately selected topics will be recruited for this survey and will be classified as “ known diabetic topics ” harmonizing to American Diabetes Association standards ( ADA 2012 ) , if they stated that they had diabetes and were on the intervention. After first testing they will be invited to the centre for elaborate testing, including an unwritten glucose tolerance trial in those without self-reported diabetes. Those who confirmed by unwritten glucose tolerance trial to hold 2-hour plasma glucose value of 11.1 mmol/L or more ( 200 mg/dL ) based on World Health Organization confer withing group standards were labelled as “ freshly detected diabetic topics ( NDD ) , ” those with 2-hour station glucose value of at least 7.8 mmol/L ( 140 mg/dL ) and less than 11.1 mmol/L ( 200 mg/dL ) as topics with IGT, and those with 2-hour station glucose value of less than 7.8 mmol/L ( 140 mg/dL ) as topics with normal glucose tolerance ( NGT ) .

For Screening of diabetic Nephropathy following standards will be adopted.

Harmonizing to the ADA standards

Phases

Albuminuria cutoff values

Clinical features

Microalbuminuria

20-199 Aµg/min

Abnormal nocturnal lessening of blood force per unit area degrees.

30-299 mg/24 H

Increase triglycerides, entire and LDL cholesterin, and saturated fatty acids.

30-299 mg/g*

Increased frequence of metabolic syndrome constituents.

Endothelial disfunction.

Association with diabetic retinopathy, amputation and cardiovascular disease.

Increased cardiovascular mortality.

Stable GFR

Macroalbuminuria

a‰?200 Aµg/min

a‰?300 mg/24 H

a‰?300 mg/g*

High blood pressure

Increased triglycerides and entire and HDL cholesterin.

Asymptomatic myocardial ischaemia.

Progressive GFR diminution

Exclusion Standards: Patients with a diagnosing of decreased nephritic map, albuminuria ( a‰?300 mg/dl ) and creatinine degrees ( a‰?2mg/dl ) , history of intoxicant consumption or smoke.

Anthropometric measurings

It ‘s included weight, tallness, and waist and will be obtained utilizing standardised techniques. Height will be measured with a tape step to the nearest centimetre. Weight will be measured with traditional spring balance that was kept on a steadfast horizontal surface. Waist will be measured utilizing a non stretchy fibre measurement tape. The organic structure mass index ( BMI ) will be calculated as the weight in kgs divided by the square of tallness in metres. Blood force per unit area will be recorded from the right arm in a sitting place to the nearest 2 millimeter Hg with a quicksilver sphygmomanometer.

Biochemical parametric quantities

Fasting plasma glucose ( glucose oxidase-peroxidase method ) , serum cholesterin ( cholesterol oxidase-peroxidase- aminopyrine method ) , serum triglycerides ( glycerol phosphate oxidase-peroxidase-amidopyrine method ) , and high-density lipoprotein ( HDL ) cholesterin ( direct methodpolyethylene glycol-pretreated enzymes ) will be measured utilizing BS200 Auto-analyzer ( Mindray, China ) . Glycated haemoglobin ( HbA1c ) will be estimated by NycoCard – HbA1c Test.

Biomarker Analysis:

Biochip Assay Methodology is based on standard immunochemical assay techniques. In most trial panels, antibodies are attached to the surface of the biochip and analyses in the patient ‘s samples binds to them. Competitive and sandwich immunochemical assay techniques are used for biochip checks. The methodological analysis adopted is panel-specific and dependent on molecular weight of the analytes of involvement. The competitory checks use an enzyme-labelled analyte for signal production whereas the sandwich check utilizes an enzyme-labelled antibody.

One biochip is used per sample to bring forth multiple trial consequences at the same time, Each biochips contain internal control sites, which are ever on the same place on every biochips. The control sites have sets target degrees in order to place problems.The sensing system is based on chemiluminescent signal. An enzyme is used to catalyze the chemical reaction on the biochip which generates the chemiluminescent signal. The light emitted from each DTRs is at the same time detected and Quantified utilizing Charge-Coupled Device ( CCD ) camera. Analyze a complete profile of biomarkers from every bit small as 7 Aµl of samples.

ELISA Based Method ;

Adiponectin, insulin, leptin, resistin and other markers that non available in biochip array will be measured by enzyme-linked immunosorbent check ( ELISA ) . In brief, monoclonal antibody specific for marker were pre-coated onto a micro home base. Standards and samples will be pipette into the Wellss, and specific marker nowadays will be bound by the immobilized antibody. After rinsing off any unbound substances, an enzyme-linked monoclonal antibody specific for marker will be added to the Wellss. After a wash to take any unbound antibody-enzyme reagent, a substrate solution was added to the Wellss ; and color developed in proportion to the sum of marker edge in the initial measure. Absorbance will be read at 450 nanometer. The values would be expressed in pictograms per millilitre units.

Statistical Analysis: Student t trial or 1-way analysis of discrepancy will be used to compare groups for uninterrupted variables, whereas I‡2 trial or Fisher exact trial as appropriate used to compare proportions. Pearson correlativity analysis will be carried out to find the relation of different biomarker with other hazard variables. Multiple additive arrested development analysis was used to find the association of important biomarker with different biochemical parametric quantities. All analyses will be done utilizing Windows-based SPSS statistical bundle and P values of & lt ; .05 will be taken as important.

4.3 Management Plan:

The research squad was established based on recommendations that “ multidisciplinary attacks to research ” is a major thrust for successful research undertakings. The research squad for this undertaking includes: Dr. Khalid Al-Rubeaan ( PI ) , Consultant Endocrinologist, Director of the University Diabetes Center Fellow the Royal College of doctor of Canada, F.R.C.P ( C ) , Dr. Khalid Siddiqui, PhD. in Biochemistry and Dr. Dhekra Al-Naqeeb, Bachelor Degree in Medicine and Surgery ( MBBS ) .

Dr. Khalid Al-Rubeaan ( PI ) is the Director of the University Diabetes Center, King Saud University. He is working as a Consultant Endocrinologist and Assistant Professor, College of Medicine at King Saud University. He is besides the Executive Director of Strategic Center for Diabetes Research, Editor-in-Chief of International Journal of Diabetes Mellitus Scientific Journal and Al-Sukari Magazine for Patient Education in the Middle East, the Head of the Saudi National Diabetes Registry and a former president of the Pan Arab Group for the Study of Endocrinology and Diabetes. His major involvement is Endocrine Disease with particular involvement on Diabetes Mellitus covering all facets i.e. basic research, instruction, bar and epidemiology. Dr. Al-Rubeaan is a member of many Diabetes Associations and Federations and had legion publications in the signifier of chapters and books or scientific documents covering many Fieldss of diabetes. Dr. Al-Rubeaan chaired many preparation classs in the field of Diabetology for doctors, pedagogues, pes attention specializer and dieticians. He had been an organiser of undergraduate classs and former caput of endocrinal division, Medical College at King Saud University. He was awarded the outstanding graduate student accomplishment by the Saudi Arabian Education Mission in 1988 and the Arabian Award for Diabetes Education by the Pan-Arab Society for Diabetes and Endocrinology in 2001. He was besides awarded the Novo Nordisk Research Merit Award in diabetes in 2002. He has obtained patent in the field of nano and IT engineering in the country of diabetes direction.

Dr. Khalid Siddiqui, is presently the Head, Basic Science ( Genetics & A ; Biochemistry ) Strategic Centre for Diabetic Research, King Saud University. He pursued his doctorial grade in the field of Molecular Genetics and biochemistry from International Max Planck Research School, Germany and grade was awarded by Goethe University Frankfurt Germany. Following his Ph.d. he worked as Postdoctoral research associate in Faculty of Life Science at The University of Manchester, England. He will be responsible for oversing the laboratory portion of the undertaking. In add-on He will besides responsible for the statistical analysis, composing consequences and manuscripts.

Dr. Dhekra Al-Naqeeb is a Research Physician in University Diabetes Center ( UDC ) , King Saud University. She will be responsible for enlisting of patients and clinical diagnosing following STRICT standards in add-on to the authorship of the studies and the manuscript.

Form RE -D1-4: ROLE AND INVOLVEMENT DURATION OF PROJECT TEAM

Team Members

Function

Duration

( MONTHS )

Senior Forces:

Dr. Khalid Al-Rubeaan

Dr. Khalid Siddiqui

Dr. Dhekra Al-Naqeeb

OTHER Forces:

Form RE- D1-5: Work Plan AND TIME SCHEDUAL

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