Follow-up of NAFLD Patients With MRI-PDFF

NCT04910178 | Completed Phase 4 FDA Drug

• 1 other identifier: BeniSuef
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The liver is a key organ in metabolism and contributes to T2DM development and insulin resistance via unclear mechanisms that may involve liver fat accumulation, inflammatory signals, and immune cells are proposed to play an important role in the pathogenesis of both NAFLD and T2DM.

Conditions

Diabetes Type 2; NAFLD

Outcome Measures

Primary Outcomes (2)

• liver fat content (percent)

  measured by MRI-PDFF

  6-months

• fatty liver staging (0, I, II, and III)

  using ultrasound

  6-months

Secondary Outcomes (7)

• Changes in Serum Gamma glutamyl transferase (γ-GT)

  6-months

• HbA1c (%)

  6-months

• Fasting and 2-hr post-prandial serum glucose (mg/dl)

  6-months

• Lipid profile

  6-months

• Changes in liver enzymes

  6-months

Study Arms (4)

Empa group

EXPERIMENTAL

patients will be given Empagliflozin 25 mg once daily

Drug: Empagliflozin 25 MG

PTX group

EXPERIMENTAL

patients will be given PTX 400 mg twice daily or 3 times daily

Drug: Pentoxifylline 400 MG

UDCA group

EXPERIMENTAL

patients will be given UDCA 500 mg twice daily

Drug: Ursodeoxycholic acid

Placebo

PLACEBO COMPARATOR

patients will be given a placebo

Other: placebo

Interventions

Empagliflozin 25 MG DRUG

tablets to be taken orally once a day

Also known as: Jardiance 25mg tablets

Empa group

Ursodeoxycholic acid DRUG

tablets to be taken orally twice a day

Also known as: Ursofalk tablets

UDCA group

Pentoxifylline 400 MG DRUG

tablets to be taken orally twice a day

Also known as: Trental tablets

PTX group

placebo OTHER

just starch tablets without any active agents

Placebo

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are willing to participate in this study
• Adults aged ≥ 18 years old presented at the clinic with a confirmed diagnosis of T2DM who are on sulfonylurea for the last 6 months at least and diagnosed with NAFLD.

You may not qualify if:

• Patients who refused to participate in this trial
• Patients diagnosed with Type 1 diabetes
• Previous history of alcohol intake
• history of recurrent attacks of ketoacidosis in a diabetic patient
• Type 2 diabetic patient with kidney dysfunction (estimated eGFR below 60ml/min/1.73m2 or CrCl below 60ml/min) or on dialysis
• Previous history of taking medication that may alter either drug efficacy (eg, corticosteroids, oral contraceptives, and thiazide diuretics)
• Evidence of another liver disease (viral hepatitis, drug-induced liver disease, autoimmune hepatitis)
• Lactating/pregnant female or children ≤ 18
• Any contraindication for Empagliflozin including:
• History of recurrent attacks of UTI or Genital infection in females
• History of recurrent foot injuries or infections
• Type 2 diabetic patient with CV disease especially NYHA classes III/ IV
• Immunocompromised patients or with a history of inflammatory, immunological, or malignant diseases.
• Any contraindication for PTX including:
• Hypersensitivity to PTX

Sponsors & Collaborators

• Asmaa Abdelfattah Elsayed: lead

Study Sites (1)

Minya University Hospital

Minya, 61118, Egypt

Location

MeSH Terms

Conditions

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

Interventions

empagliflozin; Ursodeoxycholic Acid; Pentoxifylline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Deoxycholic Acid; Cholic Acids; Bile Acids and Salts; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholanes; Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Asmaa A Elsayed, PhD

  BUC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PHD candidate in clinical pharmacy department and PI

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 2, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2021
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)