Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy | NCT03212755

Studies
Serum Immunoglobulin (G) as a Marker of Diabetic Nephropathy

NCT03212755

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 11, 2017Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Diabetic Nephropathies

Interventions

serum immunoglobulin G level

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2017Estimated

Primary Completion Date

Jun 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jul 7, 2017

First Submission Date that Met QC Criteria

Jul 7, 2017

First Posted Date

Jul 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2017

Last Update Posted Date

Jul 11, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1	Experimental	25 diabetic patients without diabetic nephropathy	Diagnostic Test: serum immunoglobulin G level
group 2	Experimental	25 type 2 diabetic patients with diabetic nephropathy	Diagnostic Test: serum immunoglobulin G level
group 3	Sham Comparator	25 healthy subjects	Diagnostic Test: serum immunoglobulin G level

Interventions

Name	Type	Description	Arm Group Labels	Other Names
serum immunoglobulin G level	Diagnostic Test	measurement of the serum level as a marker of diabetic complications	group 1 group 2 group 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients with high level of immunoglobulin in serum		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 .

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided