Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy
Serum Immunoglobulin (G ) as a Predictive Marker of Early Renal Affection in Type 2 Diabetic Patients
1 other identifier
interventional
75
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 11, 2017
July 1, 2017
1.8 years
July 7, 2017
July 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The number of patients with high level of immunoglobulin in serum
24 hours
Study Arms (3)
group 1
EXPERIMENTAL25 diabetic patients without diabetic nephropathy
group 2
EXPERIMENTAL25 type 2 diabetic patients with diabetic nephropathy
group 3
SHAM COMPARATOR25 healthy subjects
Interventions
measurement of the serum level as a marker of diabetic complications
Eligibility Criteria
You may qualify if:
- type 2 diabetic patients
You may not qualify if:
- patients with diabetes type 1 ,
- pregnant and lactating females ,
- patients with any congenital disease , Infection , Smokers , alcoholics , and drug abusers .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
July 7, 2017
First Posted
July 11, 2017
Study Start
August 1, 2017
Primary Completion
June 1, 2019
Study Completion
December 1, 2019
Last Updated
July 11, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share