Follow-up of NAFLD Patients With MRI-PDFF

Sponsor
Asmaa Abdelfattah Elsayed
Study ID
NCT04910178
Phase
PHASE4
Status
Completed

Conditions

  • Diabetes Type 2
  • NAFLD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25 MG — DRUG
    tablets to be taken orally once a day
  • Ursodeoxycholic acid — DRUG
    tablets to be taken orally twice a day
  • Pentoxifylline 400 MG — DRUG
    tablets to be taken orally twice a day
  • placebo — OTHER
    just starch tablets without any active agents

Study Details

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.

Key Dates

Start date
Dec 1, 2020
Status verified
Dec 2022
Primary completion
Dec 1, 2021
Completion
Dec 30, 2021

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empa group
    patients will be given Empagliflozin 25 mg once daily
  • Experimental: PTX group
    patients will be given PTX 400 mg twice daily or 3 times daily
  • Experimental: UDCA group
    patients will be given UDCA 500 mg twice daily
  • Placebo Comparator: Placebo
    patients will be given a placebo

Primary Outcome Measure

liver fat content (percent) [ Time Frame: 6-months ]

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