Overview

Anti-diabetic Drugs and Fatty Liver Management

Status:
Recruiting

Trial end date:
2022-09-22

Target enrollment:
0

Participant gender:
All

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

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Alexandria University

Collaborator:

Eva Pharma

Treatments:

Empagliflozin
Liraglutide
Metformin
Vildagliptin

Criteria

Inclusion Criteria:

- Type 2 DM with fatty liver disease.

- HbA1C less than 10.

Exclusion Criteria:

1. Alcohol intake.

2. BMI 40 or more.

3. CKD with e GFR less than 60.

4. chronic liver diseases (chronic viral hepatitis, autoimmune hepatitis, Wilson's
disease, hemochromatosis, alfa-1 antitrypsin deficiency)

5. Atherosclerotic cardiovascular disease.

6. Celiac disease.

7. Clinically evident liver cirrhosis.

8. 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)