Anti-diabetic Drugs and Fatty Liver Management

NCT05041673 | Unknown

• 1 other identifier: 0304932
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 DM is one of the major risk factors for development of non-alcoholic fatty liver disease. The pooled prevalence of fatty liver among diabetics is 54% (95% CI 45%-64%). Until now there is no well-established treatment for fatty liver disease. Study setting: Randomized controlled trial Study population: Patients with type 2 DM plus Fatty Liver. Arms and Interventions 1\. Experimental arms: Group 1: metformin +/- insulin +/- sulfonylurea Group 2: Metformin plus vildagliptin+/- insulin +/- sulfonylurea Group 3: Metformin plus liraglutide+/- insulin+/- sulfonylurea Group 4: Metformin plus empagliflozin +/- insulin +/- sulfonylurea

Conditions

Fatty Liver, Nonalcoholic; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in steatosis as measured using CAP score (fibroscan) and MRI

  12 months

Secondary Outcomes (2)

• Change in liver enzymes

  12 months

• Changes in fibrosis grade

  12 months

Study Arms (4)

Group 1

ACTIVE COMPARATOR

metformin +/- insulin +/- sulfonylurea

Drug: Metformin

Group 2

EXPERIMENTAL

Metformin plus vildagliptin +/- insulin +/- sulfonylurea

Drug: Metformin

Group 3

EXPERIMENTAL

Metformin plus liraglutide +/- insulin+/- sulfonylurea

Drug: Metformin

Group 4

EXPERIMENTAL

Metformin plus empagliflozin +/- insulin +/- sulfonylurea

Drug: Metformin

Interventions

Metformin DRUG

Antidiabetic drugs

Also known as: Liraglutide, empagliflozin, Vildagliptin

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 DM with fatty liver disease.
• HbA1C less than 10.

You may not qualify if:

• Alcohol intake.
• BMI 40 or more.
• CKD with e GFR less than 60.
• chronic liver diseases (chronic viral hepatitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alfa-1 antitrypsin deficiency)
• Atherosclerotic cardiovascular disease.
• Celiac disease.
• Clinically evident liver cirrhosis.
• Patients who have ever had medullary thyroid carcinoma (MTC) or who have a family member who has ever had and patients who have multiple endocrine neoplasia syndrome type 2 (MEN 2)

Sponsors & Collaborators

• Alexandria University: lead
• Eva Pharma: collaborator

Study Sites (1)

Alexandria University.

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2

Interventions

Metformin; Liraglutide; empagliflozin; Vildagliptin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 13, 2021
• Study Start: February 23, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)