Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. 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 Phase
Diabetic Nephropathies Diagnostic Test: serum immunoglobulin G level Not Applicable

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
Estimated 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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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