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NCT Number: NCT06691529

Metabolic Associated Fatty Liver Disease in Patients With Chronic Glomerular Disease

The association of metabolic associated fatty liver disease in patients with chronic glomerular disease

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

Chronic kidney disease (CKD) is associated with high morbidity and mortality, and is rapidly becoming a major burden to the global health care system.

Chronic kidney disease CKD is a complex, progressive chronic condition that is defined by either abnormality of kidney structure or function present for ≥3 months Either markers of kidney damage or decreased glomerular filtration rate may be present.

The global prevalence of CKD was estimated at 10.4-13.4% , stage 5 HD is rapidly increasing worldwide and expected to further increase in the next decade .

Metabolic associated fatty liver disease (MAFLD) is characterized by excessive hepatic fat accumulation without significant alcohol intake, use of medications causing fatty liver, or other traditional causes of fatty liver, is the most common cause of chronic liver disease worldwide, especially in developed countries . MFLD refers to a wide spectrum of liver damage, ranging from simple steatosis to non-alcoholic steatohepatitis, advanced fibrosis and cirrhosis Studies have shown that MAFLD is the underlying cause of an increasing number of extrahepatic manifestations. MAFLD is mainly linked to type II diabetes mellitus (T2DM) and cardiovascular disease (CVD), as well as a number of other severe chronic diseases including chronic kidney disease (CKD) The diagnosis of MAFLD requires the presence of hepatic steatosis plus at least one of the following three metabolic risk abnormalities: overweight/obesity, T2DM or evidence of metabolic dysregulation.

Metabolic syndrome (MetS) was defined according to the National Cholesterol Education Program ATP III criteria (16) as the presence of any three or more of the following metabolic conditions: Abdominal obesity, waist circumference ⩾ 102 cm in men and ⩾ 88 cm in women. Serum triglycerides (TG) ⩾ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides, serum high-density lipoprotein cholesterol<40 mg/dL (1.0 mmol/L) in men and<50 mg/dL (1.3 mmol/L) in women or drug treatment for low high density lipoprotein cholesterol. Blood pressure ⩾ 130/85 mmHg or drug treatment for elevated blood pressure, fasting blood glucose ⩾ 100 mg/dL (5.6 mmol/L) or drug treatment for elevated blood glucose.

Diabetes mellitus (DM) was defned as a fasting blood glucose level of ⩾125 mg/dl, or prescription of antidiabetic drugs, Hypertension was defned as systolic blood pressure (SBP) ⩾ 130 mmHg, diastolic blood pressure (DBP) ⩾ 85 mmg , or prescription of antihypertensive drugs.

A recent meta-analysis of about 10 million individuals reported a global prevalence of MAFLD of 38.8% in adults. In addition, it has been reported that MAFLD may progress to cirrhosis and promote the development of some important extrahepatic diseases, such as cardiovascular disease and chronic kidney disease (CKD).

MAFLD and CKD share some common features, including visceral obesity, T2DM, hypertension and metabolic syndrome and both diseases are also linked to an increased risk of CVD . Both diseases are progressive chronic conditions that represent a spectrum of diseases extending from relatively mild disease, with only modest changes in function, to severe debilitating disease with end-stage organ damage, necessitating either chronic dialysis or organ transplantation in order to sustain life.

The potential relationship between NAFLD and CKD has recently attracted scientists' interest. Establishing a relationship between liver and kidney injury would help to identify kidney illness sooner and enable for the selection of medicines that target both liver and kidney disease, with potentially beneficial preventative and therapeutic implications .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All CKD patient aging between (18-70) years with known tubule-glomerular diseases.
  • At any eGFR.
  • All CKD patient have either type I/II DM associated with CKD .

Exclusion criteria

  • CKD patients of Unknown etiology.
  • CKD patients with liver cirrhosis.
  • CKD patients secondry to documented diabetic nephropathy.
  • Patients with previous/current HBV or HCV.
  • Pregnant CKD patients.
  • Patient commencing any hepatotoxic medication.

Treatment and study plan

Primary outcomes

  1. association between metabolic associated fatty liver disease and chronic kidney disease

    Time frame: through study completion, an average of 1 year

    To detect the association between metabolic associated fatty liver disease and chronic kidney disease with glomerular diseaese in Assuit university hospital.

Study contacts

Contact information is provided by the study sponsor or research team.

Hussein Ahmed El_Amin

CONTACT

[email protected]

01004084187

Samar Fahmy Amin

CONTACT

[email protected]

01004084187

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

The Association of Metabolic Associated Fatty Liver Disease in Patients With Chronic Glomerular Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 15, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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