Type 2 Diabetes With Renal ManifestationsCkd&dmNCT05847400
Predictors of Chronic Kidney Disease Among Type 2 Diabetic Patients in Assiut University Hospitals
An observational study of Type 2 Diabetes With Renal Manifestations, run by Assiut University at 1 site in Egypt.
Trial summary
Predictors of Chronic Kidney Disease among Type 2 Diabetic Patients in Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes With Renal Manifestations
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: All type 2 diabetic \&ckd patient older than 18 years
Who may be able to join
- Patients with T2DM aged 18 years or older. For patients whom eGFR values < or =60 ml/min/1.73m2.
- Patient with type 2 DM and ESRD on regular HD with duration less than 1 year
Who cannot join
- Having kidney transplantation incomplete data on glycemic control. Patients with type 2 DM and ESRD on regular HD with duration more than 1 year. Pregnant woman. Patients with advanced comorbides(cardiac, hepatic,
Trial locations and contacts
1 site in 1 country.
Peter At Munir contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut
Asyut, 088
Muhammed Al Abualsaud, Master, +20 106 923 9438, Aboalsaud25@gmail.com
Peter At Munir, 01553529181
About this study
Predictors of Chronic Kidney Disease among Type 2 Diabetic Patients in Assiut University Hospitals.
Read the detailed description
Globally, the total number of people with diabetes is estimated to increase from 415 million (8.8%) in 2015 to 642 million (10.4%) in 2040, with the largest alterations expected to occur in the urban population of low- to middle-income countries (LMICs)1. Of them, type 2 diabetes mellitus (T2DM) accounts for more than 90% of people with diabetes2,3. By 2040, the difference worldwide is projected to broaden, with 477.9 million affected people living in urban areas and 163.9 million in rural areas1. It has been postulated that the burden of diabetes and its complications in the LMICs may be contributed by the economic development and rapid urbanisation via increased caloric intake and the adoption of a sedentary lifestyle2,4,5. More importantly, the most striking demo graphic change to diabetes prevalence in global terms also seems to be related to the growth of the proportion of the elderly population6. Despite rates of diabetes-related complications such as CVDs decreasing significantly in the past two decades, it has not translated nearly as well as kidney complications7. Approximately 10% of deaths in people with T2DM are attributable to kidney failure8. It is well-established that diabetes-related chronic kidney disease (CKD) is the leading cause of end-stage kidney disease (ESKD) in T2DM patients worldwide9,10.
In our study, we aim to identify and classify patients attending diabetic outpatient clinic with both CKD and
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKD patients with T2DM on regular HD | CKD patients with T2DM attending Assuit university diabetic outpatients clinic and ESRD on regular HD at dialysis unit of Assuit University Hospital | |
| CKD patients with T2DM not on regular HD | CKD patients with T2DM attending Assuit university diabetic outpatients clinic and ESRD not on regular HD at dialysis unit of Assuit University Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictors of CKD among T2DM patients attending Assiut University Hospitals. To classify our patients into stages according to KDIGO guidelines
To identify predictors of CKD among T2DM patients attending Assiut University Hospitals.
To classify our patients into stages according to KDIGO guidelines
Measured: 3 years
Secondary outcomes (1)
the possible risk factors contributing to progessing CKD in T2DM patients.
To identify the possible risk factors contributing to progessing CKD in T2DM patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Mar 2024 (estimated)
- Primary completion28 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes With Renal ManifestationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Ali Aboalsaud, Assiut University
- Investigators
- Muhammed Al Abualsaud, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847400
- Sponsor's protocol ID
- ckd in tybe 2 dm
- Acronym
- Ckd&dm
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Chronic Kidney Disease Among Type 2 Diabetic Patients in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT05847400
- Acronym / sponsor ID
- Ckd&dm / ckd in tybe 2 dm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 28 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 May 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.
Predictors of Chronic Kidney Disease among Type 2 Diabetic Patients in Assiut University Hospitals.
Detailed description
Globally, the total number of people with diabetes is estimated to increase from 415 million (8.8%) in 2015 to 642 million (10.4%) in 2040, with the largest alterations expected to occur in the urban population of low- to middle-income countries (LMICs)1. Of them, type 2 diabetes mellitus (T2DM) accounts for more than 90% of people with diabetes2,3. By 2040, the difference worldwide is projected to broaden, with 477.9 million affected people living in urban areas and 163.9 million in rural areas1. It has been postulated that the burden of diabetes and its complications in the LMICs may be contributed by the economic development and rapid urbanisation via increased caloric intake and the adoption of a sedentary lifestyle2,4,5. More importantly, the most striking demo graphic change to diabetes prevalence in global terms also seems to be related to the growth of the proportion of the elderly population6. Despite rates of diabetes-related complications such as CVDs decreasing significantly in the past two decades, it has not translated nearly as well as kidney complications7. Approximately 10% of deaths in people with T2DM are attributable to kidney failure8. It is well-established that diabetes-related chronic kidney disease (CKD) is the leading cause of end-stage kidney disease (ESKD) in T2DM patients worldwide9,10.
In our study, we aim to identify and classify patients attending diabetic outpatient clinic with both CKD and
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD patients with T2DM on regular HD | – | –CKD patients with T2DM attending Assuit university diabetic outpatients clinic and ESRD on regular HD at dialysis unit of Assuit University Hospital |
| CKD patients with T2DM not on regular HD | – | –CKD patients with T2DM attending Assuit university diabetic outpatients clinic and ESRD not on regular HD at dialysis unit of Assuit University Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All type 2 diabetic \&ckd patient older than 18 years
Key inclusion criteria (2 listed)
- Patients with T2DM aged 18 years or older. For patients whom eGFR values < or =60 ml/min/1.73m2.
- Patient with type 2 DM and ESRD on regular HD with duration less than 1 year
Key exclusion criteria (1 listed)
- Having kidney transplantation incomplete data on glycemic control. Patients with type 2 DM and ESRD on regular HD with duration more than 1 year. Pregnant woman. Patients with advanced comorbides(cardiac, hepatic,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
predictors of CKD among T2DM patients attending Assiut University Hospitals. To classify our patients into stages according to KDIGO guidelines
Time frame: 3 years
To identify predictors of CKD among T2DM patients attending Assiut University Hospitals. To classify our patients into stages according to KDIGO guidelines
1 secondary outcome
the possible risk factors contributing to progessing CKD in T2DM patients.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
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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. This study is not recruiting at the moment.
Peter At Munir contact
Muhammed Al Abualsaud principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes With Renal Manifestations, run by Assiut University at 1 site in Egypt.
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 2 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: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Al Abualsaud (+20 106 923 9438, Aboalsaud25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictors of CKD among T2DM patients attending Assiut University Hospitals. To classify our patients into stages according to KDIGO guidelines (time frame: 3 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 6 May 2023.