Effects of nutrition in diabetic/non-diabetic participants who have increased fat in the liver

Not Applicable

• Conditions: on-alcoholic fatty liver disease (NAFLD); Digestive System; Fatty (change of) liver, not elsewhere classified

• Registration Number: ISRCTN11412541
• Lead Sponsor: TWINS Digital Services India pvt ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-18
• Last Update Posted: 22 July 2024
• Study Completion: 2025-10-14

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

1. Patients with NAFLD (either ELF score > 7.7 or MRE with kPa 2.5 to 5) or with a histological diagnosis of NASH (biopsy < 6 months old)
2. Age =18 years of age of either gender
3. BMI 19 kg/m² and above
4. Non-diabetic or diabetic (HbA1c <9%) on a stable dose of antidiabetic medications for the last 3 months
5. Willing to provide written informed consent and comply with the study protocol

Exclusion Criteria

1. Those with a history of significant alcohol consumption. Significant alcohol intake is considered when alcohol consumption >7 standard drinks/week (70 g ethanol) in women and >14 standard drinks/week (140 g ethanol) in men (according to Asia-Pacific Guidelines)
2. AUDIT score >8 indicating harmful alcohol consumption
3. Patients with a diagnosis liver disease due to other etiologies such as alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson’s disease, a1-antitrypsin deficiency
4. Those with clinical evidence of hepatic decompensation such as a history of ascites, esophageal bleeding varices, or spontaneous encephalopathy
5. Those with evidence of portal hypertension such as low platelet counts (< 1.5 lakhs per microlitres), esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly (moderate, severe)
6. Child-Pugh class B/C
7. ALT and AST elevation greater than five times the upper limit of normal (ULN)
8. Alkaline phosphatase more than 2 ULN (less than 250–300 271 U/L)
9. Severe hypertension either treated or untreated. (defined as systolic blood pressure (SBP) >180 mmHg or diastolic blood pressure (DBP) >100 mmHg)
10. Patients with a history of clinically significant heart disease (New York Heart Association (NYHA) Class greater than grade II), peripheral vascular disease (history of claudication), or diagnosed pulmonary disease
11. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study
12. Change in body weight more than 5% in the last 3 months
13. History of malignancy in the last 5 years
14. Active, serious medical disease with a likely life expectancy <2 years
15. Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer, prior to randomization
16. Patients on supplements for weight loss, pioglitazone, vitamin E
17. Pregnant and lactating women and postpartum up to 2 years
18. Those with contraindications for MR elastography
19. Any other condition that, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Fibrosis score and hepatic fat content measured by magnetic resonance elastography (MRE) at 1 year<br>2. Liver fibrosis assessed using enhanced liver fibrosis (ELF) scores measured from baseline to the end of 1 year