Anti-diabetic Drugs and Fatty Liver Management

NCT ID: NCT05041673

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-23
• Study Completion Date: 2022-09-30

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

Detailed Description

Rational: 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.

NAFLD diagnostic criteria:

• Fatty Liver Index (FLI) 60 or more plus Ultrasound features of fatty liver.

• Inclusion criteria

1. Age above 18. 2- HbA1C less than 10.

Sample size: Based on the result reported by Armstrong et al, the proportion of patients on standard care who showed resolution of steatosis versus intervention group on liraglutide was 9% vs 39%, using power of 80%, precision of 5%, the minimal required sample size was 24 for each group and we increased it to 30 to compensate for drop-out. So, 120 subjects will be divided into 4 equal groups.

Study Design: Interventional (Randomized Clinical Trial) Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking. Study duration: 12 months of follow up

Data collection methods and tools

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1. Filling the pre-designed structured interview questionnaire from patients that includes:

• Demographic traits: age, sex, marital status, education, occupation and residency.
• Habits: smoking, physical exercise, dietary habits, drug use.
• Social history, focusing on smoking status, occupation, presence of children at home and plans for future pregnancy (as appropriate).
• Drug history

2. Clinical data about:

• Present/ past/ family history on thyroid diseases, and autoimmune disease.
• Comorbidities: hypertension, coronary heart disease, chronic obstructive air way disease (COPD), obesity and others.
• Medications used: dose, frequency and route of administration.
• Hospitalization.
• Body measures: weight, height, body mass index (BMI), waist circumference.
• Vital signs: pulse, blood pressure, heart rate.
• The compliance was ascertained through direct questioning at each clinic visits and by inspecting her pill bottles.
• Patient satisfaction and quality of life will be measured at baseline and at the end of Intervention.

3. Investigations

• Lab: HCV Ab, HBsAg, HBcAb, ALT, AST, GGT, FBS, HBA1c, PPBS, Fasting insulin, CBC, Cholesterol, LDL, HDL, TGs, uric acid.
• Calculation of the following score FLI, NAFLD-LFS, FIB-4, NFS.
• Imaging: ultrasound/FIBROSCAN/ MRI.
• Adverse effects of the drugs were systematically identified by careful health interview and clinical examinations. T-Bil, AST, ALT, and hematological values were measured for evaluation at every outpatient clinic visit.

Follow-up

All patients were followed up for twelve months:

• Dietary follow up.
• Liver enzymes (ALT, AST and GGT) at least every 3 months and more if clinically indicated
• Scores follow up: NFS and FIB-4 every 3 months.
• Fibroscan at end of 1-year follow up.
• MRI at end of 1-year follow up.

Conditions

Fatty Liver, Nonalcoholic; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

metformin +/- insulin +/- sulfonylurea

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Antidiabetic drugs

Group 2

Metformin plus vildagliptin +/- insulin +/- sulfonylurea

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Antidiabetic drugs

Group 3

Metformin plus liraglutide +/- insulin+/- sulfonylurea

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Antidiabetic drugs

Group 4

Metformin plus empagliflozin +/- insulin +/- sulfonylurea

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Antidiabetic drugs

Interventions

Metformin

Antidiabetic drugs

Intervention Type: DRUG

Other Intervention Names

Liraglutide; empagliflozin; Vildagliptin

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eva Pharma

INDUSTRY

Sponsor Role: collaborator

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Kamal

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alexandria University.

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0304932

Identifier Type: -

Identifier Source: org_study_id