NCT06071208

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Oct 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Oct 2023Dec 2028

First Submitted

Initial submission to the registry

October 3, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

October 14, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2028

Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

October 3, 2023

Last Update Submit

October 6, 2023

Conditions

Diabetes Mellitus Without Complication

Outcome Measures

Primary Outcomes (1)

  • prevention of diabetic complications

    glomerular filtration rate will be measured at the beginning of the study and at the end

    5 years

Study Arms (2)

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

GliflozinDRUG

to study whether the use of gliflozin prevented diabetic complications

cases of studycontrols of study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • diabetics,prediabetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Study Officials

  • Usama Sharaf El Din, MD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Fayed, MD

CONTACT

+201142700904dr.fayed@gmail.com

Mohammed Hegazy, MD

CONTACT

+201205408765mohammed.hegazy@ngu.edu.eg/

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of internal medicine

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 6, 2023

Study Start

October 14, 2023

Primary Completion (Estimated)

October 14, 2028

Study Completion (Estimated)

December 14, 2028

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share