Risk of CKD in Diabetic Patients With MAFLD

NCT ID: NCT06304844

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-20

Study Completion Date

2025-02-01

Brief Summary

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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

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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

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Type 2 Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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diabetic without MAFLD

patients with type 2 DM but has no evidence of MAFLD

No interventions assigned to this group

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

transient elastography (Fibroscan)

Intervention Type DIAGNOSTIC_TEST

conduct fibroscan for patients with (MAFLD by abdominal ultrasonography)

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

transient elastography (Fibroscan)

Intervention Type DIAGNOSTIC_TEST

conduct fibroscan for patients with (MAFLD by abdominal ultrasonography)

Interventions

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transient elastography (Fibroscan)

conduct fibroscan for patients with (MAFLD by abdominal ultrasonography)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetic patients
* Willing and agreed to be included in the study.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahmoud Ismail

assistant lecturer - internal medicine department

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmed Ismail, ass. lecturer

Role: CONTACT

00201019472026

Other Identifiers

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Soh-Med-24-02-06MD

Identifier Type: -

Identifier Source: org_study_id

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