Clinical trial NCT05813301: NAFLD in Patient of Hypothyroidism
Official title: Early Predictors of NAFLD in Patient of Hypothyroidism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: NAFLD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-04-14
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hypothyroidism patient

Brief summary: Nonalcoholic fatty liver disease (NAFLD) is the most important chronic liver disease in the western world, affecting almost 30% of the general population. Moreover, the prevalence of NAFLD can be higher in type 2 diabetic patients and obese patients, affecting up to 90% of people with a body mass index higher than 40 kg/m2. NAFLD is also the most rapidly increasing cause of hepatic cirrhosis requiring hepatic transplantation in the future. The pathophysiology of NAFLD is complex and involves multiple hits, but the principal contributing factor to its development is hepatic lipid accumulation, which leads to hepatic insulin resistance

Detailed description: Nonalcoholic fatty liver disease (NAFLD) is the most important chronic liver disease in the western world, affecting almost 30% of the general population. Moreover, the prevalence of NAFLD can be higher in type 2 diabetic patients and obese patients, affecting up to 90% of people with a body mass index higher than 40 kg/m2. NAFLD is also the most rapidly increasing cause of hepatic cirrhosis requiring hepatic transplantation in the future. The pathophysiology of NAFLD is complex and involves multiple hits, but the principal contributing factor to its development is hepatic lipid accumulation, which leads to hepatic insulin resistance

Thyroid hormones are crucial in multiple physiological processes like homeostasis, mineral, lipid, carbohydrates, and protein metabolisms. Lipid metabolism has been reported, such as increased metabolic rate, weight loss, lipolysis, and lowering serum cholesterol levels. The physiological process of thyroid hormones (TH) affects almost every organ, and the liver is one of the most critical targets of TH.. Low thyroid hormone function may cause hypercholesterolemia which plays a fundamental role in the pathophysiology of hypothyroidism-induced NAFLD The prevalence of NAFLD among the population drastically increased in the last twenty years. NAFLD manifests itself in various ways in people worldwide, affecting both the female and male sex. The global prevalence of NAFLD is 25 percent, which is approximately as high as one billion and growing. One of the most common causes of chronic liver disease in the United States is NAFLD. It affects 80 to 100 million people, and approximately 25% of the cases progress to NASH. NAFLD includes a wide range of histopathological conditions such as non-alcoholic fatty liver (NAFL), non-alcoholic steatohepatitis (NASH), fibrosis, NASH cirrhosis, and NASH-related hepatocellular carcinoma (HCC). NAFLD is a diagnosis of exclusion. The number of NASH patients with cirrhosis is rising, resulting in an increase in liver transplantation for end-stage cirrhosis

. Accumulation of the lipids causes oxidative stress and inflammatory response in the liver . Another factor that may be involved in the thyroid-liver complex is leptin. Leptin is elevated in hypothyroid patients and is also elevated in NAFLD patients. Leptin can promote hepatic insulin resistance and play a role in hepatic fibrogenesis There is no drug therapy for hypothyroidism-induced NAFLD that is currently approved. Steatosis can be reduced through structured lifestyle changes such as weight loss, dietary changes such as reduced drinking of alcohol, decreasing intake of food and drinks that have a high level of fructose, and increased daily activities and workouts

Eligibility criteria: Inclusion Criteria:All cases of hypothyroidism -

Exclusion Criteria:Diabetic Patient , obesity grade 2

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Primary outcomes:
measure: to estimate the percentage of NAFLD in patients of hypothyoidism
timeFrame: in about one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: wael ahmed abbas, prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: walaa anwer shehata, prof
role: STUDY_DIRECTOR
affiliation: Assiut University
name: mena sawerss fathy, residant
role: PRINCIPAL_INVESTIGATOR
References:
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