Type 2 DiabetesNCT06304844
Risk of CKD in Diabetic Patients With MAFLD
An observational study of Type 2 Diabetes, run by Sohag University.
Trial summary
This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- transient elastography (Fibroscan)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2024to 1 Feb 2025
- 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: The study population for this study comprises individuals diagnosed with type 2 diabetes mellitus either with or without MAFLD. The MAFLD group will encompass individuals meeting standardized diagnostic criteria for MAFLD and having a confirmed diagnosis of type 2 diabetes. Participants with comorbidities, such as viral hepatitis, cirrhosis, and cancers, will be excluded to ensure a focused study population. The chosen sample size of 300 individuals will allow for a robust examination of the prevalence of chronic kidney disease and associated risk factors within this specific cohort.
Who may be able to join
- Type 2 diabetic patients
- Willing and agreed to be included in the study.
Who cannot join
- Type 1 diabetic patients or non-diabetic patients.
- Patient with known glomerulonephritis.
- Patient with diagnosis of or clinical features that are suspicious for another systemic disease that commonly causes kidney disease (e.g., connective tissue disorders, HIV).
- Patient with evidence of alternative kidney disease like (Documented obstructive uropathy, etc.)
- Patient with history of kidney transplantation.
- Patient with end stage renal disease or on dialysis.
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- Patients with active malignancy.
- Individuals with a history of hepatitis B surface antigen or hepatitis C antibody positivity.
- history of excessive alcohol consumption (⩾30 g/day in men and ⩾20 g/day in women)
- Decompensated liver cirrhosis.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessing the Risk of Chronic Kidney Disease Associated With Metabolic Dysfunction-Associated Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus
This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions.
Read the detailed description
investigators plan to enroll 300 participants with type 2 DM to comprehensively investigate the risk of chronic kidney disease (CKD) in individuals diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus.
In this study, the participant population will be grouped based on presence of MAFLD or not into 2 groups, then the group with MAFLD will be subdivided into subgroups based on the degree of hepatic involvement, considering both controlled attenuation parameter (CAP) values for steatosis and liver stiffness measurements for fibrosis via fibro scan device. This grouping strategy aims to categorize individuals into distinct cohorts, such as Low Hepatic Involvement and High Hepatic Involvement groups, facilitating a nuanced exploration of the association between hepatic conditions and the risk of chronic kidney disease (CKD) in the context of metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes
- Being tested
- transient elastography (Fibroscan)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transient elastography (Fibroscan)Diagnostic test
conduct fibroscan for patients with (MAFLD by abdominal ultrasonography)
| Study group | Role | What they receive |
|---|---|---|
| diabetic without MAFLD | patients with type 2 DM but has no evidence of MAFLD | |
| diabetic with MAFLD (high hepatic involvement) | patients with type 2 DM and have evidence of MAFLD (according to abdominal ultrasonography) and have high controlled attenuation parameter and liver stiffness measurement in Fibroscan Receives: Diagnostic Test: transient elastography (Fibroscan) | |
| diabetic with MAFLD (low hepatic involvement) | patients with type 2 DM and have evidence of MAFLD (according to abdominal ultrasonography) and have low controlled attenuation parameter and liver stffiness measurement in Fibroscan Receives: Diagnostic Test: transient elastography (Fibroscan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD
utilizing standardized diagnostic criteria for CKD including estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR)
Measured: 6 months from the start of participants recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start20 Apr 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Ismail, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304844
- Sponsor's protocol ID
- Soh-Med-24-02-06MD
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Risk of Chronic Kidney Disease Associated With Metabolic Dysfunction-Associated Fatty Liver Disease in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06304844
- Acronym / sponsor ID
- Soh-Med-24-02-06MD
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 12 Mar 2024 (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.
This cross-sectional study of 300 participants investigates the risk of chronic kidney disease (CKD) in individuals with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes. By evaluating hepatic measurements and metabolic markers, the study aims to identify key risk factors for CKD in this population, contributing valuable insights to inform targeted interventions.
Detailed description
investigators plan to enroll 300 participants with type 2 DM to comprehensively investigate the risk of chronic kidney disease (CKD) in individuals diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus.
In this study, the participant population will be grouped based on presence of MAFLD or not into 2 groups, then the group with MAFLD will be subdivided into subgroups based on the degree of hepatic involvement, considering both controlled attenuation parameter (CAP) values for steatosis and liver stiffness measurements for fibrosis via fibro scan device. This grouping strategy aims to categorize individuals into distinct cohorts, such as Low Hepatic Involvement and High Hepatic Involvement groups, facilitating a nuanced exploration of the association between hepatic conditions and the risk of chronic kidney disease (CKD) in the context of metabolic dysfunction-associated fatty liver disease (MAFLD) and type 2 diabetes mellitus.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| diabetic without MAFLD | – | –patients with type 2 DM but has no evidence of MAFLD |
| diabetic with MAFLD (high hepatic involvement) | – | Diagnostic Test: transient elastography (Fibroscan)patients with type 2 DM and have evidence of MAFLD (according to abdominal ultrasonography) and have high controlled attenuation parameter and liver stiffness measurement in Fibroscan |
| diabetic with MAFLD (low hepatic involvement) | – | Diagnostic Test: transient elastography (Fibroscan)patients with type 2 DM and have evidence of MAFLD (according to abdominal ultrasonography) and have low controlled attenuation parameter and liver stffiness measurement in Fibroscan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for this study comprises individuals diagnosed with type 2 diabetes mellitus either with or without MAFLD. The MAFLD group will encompass individuals meeting standardized diagnostic criteria for MAFLD and having a confirmed diagnosis of type 2 diabetes. Participants with comorbidities, such as viral hepatitis, cirrhosis, and cancers, will be excluded to ensure a focused study population. The chosen sample size of 300 individuals will allow for a robust examination of the prevalence of chronic kidney disease and associated risk factors within this specific cohort.
Key inclusion criteria (2 listed)
- Type 2 diabetic patients
- Willing and agreed to be included in the study.
Key exclusion criteria (10 listed)
- Type 1 diabetic patients or non-diabetic patients.
- Patient with known glomerulonephritis.
- Patient with diagnosis of or clinical features that are suspicious for another systemic disease that commonly causes kidney disease (e.g., connective tissue disorders, HIV).
- Patient with evidence of alternative kidney disease like (Documented obstructive uropathy, etc.)
- Patient with history of kidney transplantation.
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 |
|---|---|---|
| transient elastography (Fibroscan)conduct fibroscan for patients with (MAFLD by abdominal ultrasonography) | Diagnostic test | diabetic with MAFLD (high hepatic involvement), diabetic with MAFLD (low hepatic involvement) |
Primary outcome
Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD
Time frame: 6 months from the start of participants recruitment
utilizing standardized diagnostic criteria for CKD including estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by Sohag 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 2 inclusion and 10 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 18 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ismail, ass. lecturer (00201019472026, ahmed.zayed@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the number of participant with eGFR<60 ml/min/1.73 m2 or albuminuria (urinary albumin-to-creatinine ratio (ACR) ⩾3 mg/mmol) in patients with type 2 DM and MAFLD (time frame: 6 months from the start of participants recruitment). 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 18 Mar 2024.