Prevent Diabetic Kidney Disease Among Egyptians

October 6, 2023 updated by: Ahmed Abdelkawi Hammad, Fayoum University

The National Plan To Prevent Diabetic Kidney Disease Among Egyptians: A Prospective Multicenter Randomized Controlled Study

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • diabetics,prediabetics

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cases of study
Patients is diabetes whether recently discovered or long standing diabetes
Drug: Gliflozin
to study whether the use of gliflozin prevented diabetic complications
controls of study
prediabetics ,or patients with clinical manifestations of insulin resistance eg acanthosis negricans
Drug: Gliflozin
to study whether the use of gliflozin prevented diabetic complications

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Collaborators

Cairo University
NewGiza University

Investigators

  • Study Director: Usama Sharaf El Din, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 14, 2023

Primary Completion (Estimated)

October 14, 2028

Study Completion (Estimated)

December 14, 2028

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCG 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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