Chronic Kidney Disease PatientsCKDNCT06802978
Lipid Profile in Diabetic and Non Diabetic CKD Patients
An observational study of Chronic Kidney Disease Patients, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this observational study is to compare blood lipid (fat) levels in participants with chronic kidney disease (CKD) with diabetes and without diabetes and who over 20 years old. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Disease Patients
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to Jun 2026
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who met all the inclusion criteria were selected randomly. No distinction is made between males and females.
Who may be able to join
- Patients of chronic kidney disease (CKD) presenting to the Sohag University Hospital
- Patients aged above 20 years of age.
- All patients who have given consent for enrolling into the study.
Who cannot join
- Patients aged 20 years of age or below.
- Patients on lipid-lowering drugs.
- Kidney transplanted patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mahmoud Ibrahim Yousef contact
Egypt1 site, 1 recruiting
- Recruiting
Department of Internal Medicine , Sohag University Hospital.
Sohag
Shaimaa Mahmoud Elsayed Abdel-Raheem, +201119193276, shimaa4848@gmail.com
Mahmoud Ibrahim Yousef, +201065964083
About this study
Official title: Study of Lipid Profile in Diabetic and Non Diabetic Chronic Kidney Disease Patients in Sohag University Hospital
The goal of this observational study is to compare blood lipid (fat) levels in participants with chronic kidney disease (CKD) with diabetes and without diabetes and who over 20 years old.
The main question this study aims to answer is:
Read more
Does having diabetes make fat problems worse in people with chronic kidney disease (CKD), or is there no connection between them?
Researchers will compare the blood lipid (fat) levels in people with chronic kidney disease (CKD) who have diabetes and those without diabetes to see if having diabetes makes lipid problems worse in CKD patients, or if there is no connection between diabetes and changes in lipid levels.
Participants will need to fast for 10 hours before undergoing this test. This means not eating any food or drinking anything except water.
Samples will be taken and sent to laboratory immediately.
- Conditions
- Chronic Kidney Disease Patients
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 |
|---|---|---|
| Diabetic CKD patients | This group includes participants aged over 20 years who have been diagnosed with both chronic kidney disease (CKD) and diabetes mellitus. | |
| Non-diabetic CKD patients | participants aged over 20 years who have been diagnosed with chronic kidney disease (CKD) but do not have a current or past diagnosis of diabetes mellitus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment and comparison of the lipid profile between diabetic and non-diabetic chronic kidney disease patients using the colorimetric method on a fully automated biochemistry analyser.
Lipid profile were assessed in samples of chronic kidney disease patients , both with diabetes and without diabetes, after obtaining informed consent to compare lipid profile between these two groups.
Overnight fasting samples were taken and sent to the laboratory immediately. Serum was separated within 2 hours after collection to prevent artifactual changes in the concentration of HDL. After clot retraction occurred, the serum was transferred to a centrifuge tube and centrifuged at 2000 rpm for 5 minutes. The clear supernatant serum was then pipetted out using dry piston pipettes with disposable tips and stored in dry thin walled vials at 4°C. The samples were analyzed on the same day.
The following parameters were analyzed using the colorimetric method on a fully automated biochemistry analyser.
- Serum Cholesterol
- Serum Triglyceride
- Serum HDL (high-density lipoprotein)
- Serum LDL ( low-density lipoprotein)
- Serum VLDL (very low-density lipoprotein)
Measured: January 2025 to January 2026.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Feb 2025
- Primary completion30 Jan 2026
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease PatientsStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mahmoud Elsayed Abdel-Raheem, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802978
- Sponsor's protocol ID
- Soh-Med--25-1-07MS
- Acronym
- CKD
- Status last verified
- Jun 2026
- First submitted
- 26 Jan 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Lipid Profile in Diabetic and Non Diabetic Chronic Kidney Disease Patients in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT06802978
- Acronym / sponsor ID
- CKD / Soh-Med--25-1-07MS
- Conditions
- Chronic Kidney Disease Patients
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 Jan 2025 (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.
The goal of this observational study is to compare blood lipid (fat) levels in participants with chronic kidney disease (CKD) with diabetes and without diabetes and who over 20 years old.
The main question this study aims to answer is:
Does having diabetes make fat problems worse in people with chronic kidney disease (CKD), or is there no connection between them?
Researchers will compare the blood lipid (fat) levels in people with chronic kidney disease (CKD) who have diabetes and those without diabetes to see if having diabetes makes lipid problems worse in CKD patients, or if there is no connection between diabetes and changes in lipid levels.
Participants will need to fast for 10 hours before undergoing this test. This means not eating any food or drinking anything except water.
Samples will be taken and sent to laboratory immediately.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic CKD patients | – | –This group includes participants aged over 20 years who have been diagnosed with both chronic kidney disease (CKD) and diabetes mellitus. |
| Non-diabetic CKD patients | – | –participants aged over 20 years who have been diagnosed with chronic kidney disease (CKD) but do not have a current or past diagnosis of diabetes mellitus. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who met all the inclusion criteria were selected randomly. No distinction is made between males and females.
Key inclusion criteria (3 listed)
- Patients of chronic kidney disease (CKD) presenting to the Sohag University Hospital
- Patients aged above 20 years of age.
- All patients who have given consent for enrolling into the study.
Key exclusion criteria (3 listed)
- Patients aged 20 years of age or below.
- Patients on lipid-lowering drugs.
- Kidney transplanted patients.
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
Assessment and comparison of the lipid profile between diabetic and non-diabetic chronic kidney disease patients using the colorimetric method on a fully automated biochemistry analyser.
Time frame: January 2025 to January 2026.
Lipid profile were assessed in samples of chronic kidney disease patients , both with diabetes and without diabetes, after obtaining informed consent to compare lipid profile between these two groups. Overnight fasting samples were taken and sent to the laboratory immediately. Serum was separated within 2 hours after collection to prevent artifactual changes in the concentration of HDL. After clot retraction occurred, the serum was transferred to a centrifuge tube and centrifuged at 2000 rpm for 5 minutes. The clear supernatant serum was then pipetted out using dry piston pipettes with disposable tips and stored in dry thin walled vials at 4°C. The samples were analyzed on the same day. The following parameters were analyzed using the colorimetric method on a fully automated biochemistry analyser. 1. Serum Cholesterol 2. Serum Triglyceride 3. Serum HDL (high-density lipoprotein) 4. Serum LDL ( low-density lipoprotein) 5. Serum VLDL (very low-density lipoprotein)
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 26 Jun 2026.
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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.
Mahmoud Ibrahim Yousef contact
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 Chronic Kidney Disease Patients, run by Sohag 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. 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?
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 Shaimaa Mahmoud Elsayed Abdel-Raheem (+201119193276, shimaa4848@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment and comparison of the lipid profile between diabetic and non-diabetic chronic kidney disease patients using the colorimetric method on a fully automated biochemistry analyser. (time frame: January 2025 to January 2026.). 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 26 Jun 2026.