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Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT03212755
Recruitment Status : Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Seham Mohammed Ali, Assiut University

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
Diabetic Nephropathies Diagnostic Test: serum immunoglobulin G level

Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. The number of patients with high level of immunoglobulin in serum [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
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 .

Responsible Party: Seham Mohammed Ali, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03212755     History of Changes
Other Study ID Numbers: PRUD
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs