Diabetes Mellitus Without ComplicationNCT06071208
Prevent Diabetic Kidney Disease Among Egyptians
An observational study of Diabetes Mellitus Without Complication, run by Fayoum University.
Trial summary
Study of the possibility to prevent the development of Diabetic kidney disease in type 2 diabetic patients Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Without Complication
- What is being tested?
- Gliflozin
- How many people
- 10,000 participants
- Where
- No sites listed yet
- Study dates
- 14 Oct 2023to 14 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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
Who may be able to join
- diabetics,prediabetics
Who cannot join
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Diabetes Mellitus Without Complication
- Being tested
- Gliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GliflozinDrug
to study whether the use of gliflozin prevented diabetic complications
| Study group | Role | What they receive |
|---|---|---|
| cases of study | Patients is diabetes whether recently discovered or long standing diabetes Receives: Drug: Gliflozin | |
| controls of study | prediabetics ,or patients with clinical manifestations of insulin resistance eg acanthosis negricans Receives: Drug: Gliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevention of diabetic complications
glomerular filtration rate will be measured at the beginning of the study and at the end
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start14 Oct 2023 (estimated)
- Primary completion14 Oct 2028 (estimated)
- Study completion14 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Without ComplicationStudies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University, NewGiza University
- Responsible party
- Principal investigator, Ahmed Abdelkawi Hammad, Fayoum University
- Investigators
- Usama Sharaf El Din, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071208
- Sponsor's protocol ID
- VCG 6
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The National Plan To Prevent Diabetic Kidney Disease Among Egyptians: A Prospective Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06071208
- Acronym / sponsor ID
- VCG 6
- Conditions
- Diabetes Mellitus Without Complication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Collaborators
- Cairo University, NewGiza University
- Study start
- 14 Oct 2023 (estimated)
- Primary completion
- 14 Oct 2028 (estimated)
- Study completion
- 14 Dec 2028 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases of study | – | Drug: GliflozinPatients is diabetes whether recently discovered or long standing diabetes |
| controls of study | – | Drug: Gliflozinprediabetics ,or patients with clinical manifestations of insulin resistance eg acanthosis negricans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- diabetics,prediabetics
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gliflozinto study whether the use of gliflozin prevented diabetic complications | Drug | cases of study, controls of study |
Primary outcome
prevention of diabetic complications
Time frame: 5 years
glomerular filtration rate will be measured at the beginning of the study and at the end
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Usama Sharaf El Din, MD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Without Complication, run by Fayoum University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Fayed, MD (+201142700904, dr.fayed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevention of diabetic complications (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.