Clinical trial NCT05694923: Effect of Sodium Glucose Cotransporter Inhibitors Fatty Liver Disease Patients Fatigue Assessment
Official title: Effect of Sodium Glucose Cotransporter Inhibitors on Fatty Liver Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver Disease
Keywords: Fatty Liver Nonalcoholic nondiabetic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center clinical randomized trial open labelled study patients of non diabetic non alcoholic fatty liver from outpatient clinic at assiut university will be randomized and recruited into arms Group A Will receive empaglifizon sodium glucose cotransporter in minimum dose 10 mg Group B Will be Instructed for diet control
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) has become a major health problem worldwide with an increasing prevalence ranging from 13% in Africa to 42% in South-East Asia. The term NAFLD includes a variety of diseases, ranging from liver fat deposition in more than 5% of hepatocytes (steatosis-non-alcoholic fatty liver (NAFL)) to necroinflammation and fibrosis (non-alcoholic steatohepatitis (NASH)), which can progress into NASH-cirrhosis, and eventually to hepatocellular carcinoma 1 Lifestyle modifications remain the cornerstone of NAFLD treatment, even though various pharmaceutical interventions are currently under clinical trial. Among them, sodium-glucose co-transporter type-2 inhibitors (SGLT-2i) are emerging as promising agents. Processes regulated by SGLT-2i, such as endoplasmic reticulum (ER) and oxidative stress, low-grade inflammation, autophagy and apoptosis are all implicated in NAFLD pathogenesis 2

In non-DM patients, only a small single center study exists which studied 12 patients under dapagliflozin and 10 patients under teneligliptin, a DPP4 inhibitor, for a total of 12 weeks, showing that after this intervention period, serum transaminases were decreased in both groups, while in the dapagliflozin group, total body water and body fat decreased, leading to decreased total body weight.3

Detailed description: Introduction :

Non-alcoholic fatty liver disease (NAFLD) has become a major health problem worldwide with an increasing prevalence ranging from 13% in Africa to 42% in South-East Asia. The term NAFLD includes a variety of diseases, ranging from liver fat deposition in more than 5% of hepatocytes (steatosis-non-alcoholic fatty liver (NAFLD)) to necroinflammation and fibrosis (non-alcoholic steatohepatitis (NASH)), which can progress into NASH-cirrhosis, and eventually to hepatocellular carcinoma 1 Lifestyle modifications remain the cornerstone of NAFLD treatment, even though various pharmaceutical interventions are currently under clinical trial. Among them, sodium-glucose co-transporter type-2 inhibitors (SGLT-2i) are emerging as promising agents. Processes regulated by SGLT-2i, such as endoplasmic reticulum (ER) and oxidative stress, low-grade inflammation, autophagy and apoptosis are all implicated in NAFLD pathogenesis 2

In non-DM patients, only a small single center study exists which studied 12 patients under dapagliflozin and 10 patients under teneligliptin, a DPP4 inhibitor, for a total of 12 weeks, showing that after this intervention period, serum transaminases were decreased in both groups, while in the dapagliflozin group, total body water and body fat decreased, leading to decreased total body weight.3

Aim of the study :

To evaluate efficacy of sodium glucose cotransporter inhibitors to improve outecomes among non diabetic non alcoholic fatty liver patients

Designs Single center clinical randomized trial open labelle patients of non diabetic non alcoholic fatty liver from outpatient clinic at assiut university will be randomized and recruited into arms Group A Will receive empaglifizon sodium glucose cotransporter in minimum dose 10 mg Group B Will be Instructed for diet control

All patients will be initially evaluated Full history medical history include Age .Sex Family history of DM ,HX OF HTN DRUG INTAKE history of ALCOHOL intake ..smoking Hx of fatigue Examination weight ,BMI ,waist circumference ,skin manifestation of insulin resistance

Investigation :

Liver enzymes (AlT ...AST) Serology HCV Ab,HBsAg Fasting blood glucose ,2 hour blood glucoe HBA1C Lipid profile ,urine analysis TSH fatigue scal assessment ABDOMINAL US WILL BE DONE FOR ALL PATINTS Assesment of liver steatosis and fibrosis Fibroscan will be done initially for all cases

Eligibility criteria: Inclusion Criteria:

* non alcoholic fatty liver patients diagnosed at outpatient clinic of Assiut university

Exclusion Criteria:

- DM Patient Patient with viral hepatitis C,B Patient with hypothyroidism Patient with hepatotoxic drugs

Primary outcomes:
measure: To evaluate efficacy of sodium glucose cotransporter inhibitors to reduce hepatic steatosis and fibrosis among non diabetic non alcoholic fatty liver patients
timeFrame: 3 MONTHS
Secondary outcomes:
measure: fatigue assessment
timeFrame: 6 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
city: Assiut
country: Egypt
facility: Bahaa Osman
Study officials:
affiliation: Assiut University
name: bahaa osman taha
role: PRINCIPAL_INVESTIGATOR
References: