Back to resultsSerum Immunoglobulin (G) as a Marker of Diabetic Nephropathy
Primary Purpose
Diabetic Nephropathies
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
serum immunoglobulin G level
Sponsored by
About this trial
This is an interventional screening trial for Diabetic Nephropathies
Eligibility Criteria
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 .
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
group 1
group 2
group 3
Arm Description
25 diabetic patients without diabetic nephropathy
25 type 2 diabetic patients with diabetic nephropathy
25 healthy subjects
Outcomes
Primary Outcome Measures
The number of patients with high level of immunoglobulin in serum
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03212755
Brief Title
Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy
Official Title
Serum Immunoglobulin (G ) as a Predictive Marker of Early Renal Affection in Type 2 Diabetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2017 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
25 diabetic patients without diabetic nephropathy
Arm Title
group 2
Arm Type
Experimental
Arm Description
25 type 2 diabetic patients with diabetic nephropathy
Arm Title
group 3
Arm Type
Sham Comparator
Arm Description
25 healthy subjects
Intervention Type
Diagnostic Test
Intervention Name(s)
serum immunoglobulin G level
Intervention Description
measurement of the serum level as a marker of diabetic complications
Primary Outcome Measure Information:
Title
The number of patients with high level of immunoglobulin in serum
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 .
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy
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