Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy

Sponsor

Assiut University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03212755

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Diabetes mellitus is a chronic disease that affects 366 million people worldwide ( 6.4 % of the adult population ) and is expected to rise to 522 million by 2030 . Diabetic nephropathy occurs in approximately one - third of all people with diabetes and is the leading cause of renal failure in developed and developing countries Diabetic nephropathy is a severe complication occurring in diabetic patients and it is associated with an increased risk of all- cause mortality , cardiovascular disease and progression to end stage renal disease , requiring costly renal replacement therapy in the form of dialysis or transplantation

Condition or Disease	Intervention/Treatment	Phase
Diabetic Nephropathies	Diagnostic Test: serum immunoglobulin G level	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Serum Immunoglobulin (G ) as a Predictive Marker of Early Renal Affection in Type 2 Diabetic Patients

Anticipated Study Start Date :

Aug 1, 2017

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group 1 25 diabetic patients without diabetic nephropathy	Diagnostic Test: serum immunoglobulin G level measurement of the serum level as a marker of diabetic complications
Experimental: group 2 25 type 2 diabetic patients with diabetic nephropathy	Diagnostic Test: serum immunoglobulin G level measurement of the serum level as a marker of diabetic complications
Sham Comparator: group 3 25 healthy subjects	Diagnostic Test: serum immunoglobulin G level measurement of the serum level as a marker of diabetic complications

Arm

Intervention/Treatment

Experimental: group 1

25 diabetic patients without diabetic nephropathy

Diagnostic Test: serum immunoglobulin G level

measurement of the serum level as a marker of diabetic complications

Experimental: group 2

25 type 2 diabetic patients with diabetic nephropathy

Diagnostic Test: serum immunoglobulin G level

measurement of the serum level as a marker of diabetic complications

Sham Comparator: group 3

25 healthy subjects

Diagnostic Test: serum immunoglobulin G level

measurement of the serum level as a marker of diabetic complications

Outcome Measures

Primary Outcome Measures

The number of patients with high level of immunoglobulin in serum [24 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

type 2 diabetic patients

Exclusion Criteria:

patients with diabetes type 1 ,
pregnant and lactating females ,
patients with any congenital disease , Infection , Smokers , alcoholics , and drug abusers .