Prevent Diabetic Kidney Disease Among Egyptians | NCT06071208

Studies
Prevent Diabetic Kidney Disease Among Egyptians

NCT06071208

Sponsor

Fayoum University

Status

Not yet recruiting

Last Update Posted

Oct 10, 2023Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Diabetes Mellitus Without Complication

Interventions

Gliflozin

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 14, 2023Estimated

Primary Completion Date

Oct 14, 2028Estimated

Completion Date

Dec 14, 2028Estimated

First Submitted Date

Oct 3, 2023

First Submission Date that Met QC Criteria

Oct 3, 2023

First Posted Date

Oct 6, 2023Actual

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

Oct 6, 2023

Last Update Posted Date

Oct 10, 2023Actual

Name	Class
Cairo University	OTHER
NewGiza University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

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

Study of the possibility to prevent the development of Diabetic kidney disease in type 2 diabetic patients

Detailed Description

Study of the possible role of the SGLT2 inhibitors to prevent the development of frank type2 DM among prediabetic candidates.

Study of the possible role of the SGLT2 inhibitors to prevent the development of diabetic complications, namely diabetic kidney disease, diabetic retinopathy and neuropathy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cases of study		Patients is diabetes whether recently discovered or long standing diabetes	Drug: Gliflozin
controls of study		prediabetics ,or patients with clinical manifestations of insulin resistance eg acanthosis negricans	Drug: Gliflozin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gliflozin	Drug	to study whether the use of gliflozin prevented diabetic complications	cases of study controls of study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevention of diabetic complications	glomerular filtration rate will be measured at the beginning of the study and at the end	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diabetics,prediabetics

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

diabetics aged 18 years and above,male or females will be subjected to assessment of kidney functions at the beginning of the study and at the end to assess possibility of protective effect of SGLT-2,assessmentof other diabetic complications will be done also. Prediabetics will subjected to same assessment also

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Fayed, MD	Contact	+201142700904		dr.fayed@gmail.com
Mohammed Hegazy, MD	Contact	+201205408765		mohammed.hegazy@ngu.edu.eg/

Overall Officials

Name	Affiliation	Role
Usama Sharaf El Din, MD	Cairo University	Study Director

Locations

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

Intervention Browse Module

MeSH Terms

ID	Term
D000077203	Sodium-Glucose Transporter 2 Inhibitors

Ancestor Terms

ID	Term
D045504	Molecular Mechanisms of Pharmacological Action
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D007004	Hypoglycemic Agents

Browse Leaves

Not provided

Browse Branches

Not provided