NCT05942963

Brief Summary

This clinical trial will yield results about the therapeutic effect of combining pioglitazone with SGLT2i in people suffering from NAFLD associated with T2DM. Study participants will be asked to fill out a few questions on proforma that will obtain demographic information as well as information relating to their health. In addition, some blood tests will be done following standard procedures.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

July 12, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 16, 2023

Last Update Submit

July 11, 2023

Conditions

Non-Alcoholic Fatty Liver DiseaseType2diabetes

Outcome Measures

Primary Outcomes (2)

  • A change in liver steatosis will be assessed through fibro CAP score.

    Fibro-controlled attenuation parameter (fibro CAP). The parameter range is commonly between 100 and 400 dB/m, and the greater the reading worse will be the outcome.

    Will be assessed at enrollment.

  • A change in liver steatosis will be assessed through fibro CAP score.

    Fibro-controlled attenuation parameter (fibro CAP). The parameter range is commonly between 100 and 400 dB/m, and the greater the reading worse will be the outcome.

    Will be assessed at 168th day post enrollment.

Secondary Outcomes (46)

  • change in SF-36 scores

    Quality of life will be assessed 84th day post enrollment.

  • change in SF-36 scores

    Quality of life will be assessed at day 252 post enrollment.

  • change in liver fibrosis will be assessed through the FIB-4 index.

    at enrollment.

  • change in liver fibrosis will be assessed through the FIB-4 index.

    84th day post enrollment.

  • change in liver fibrosis will be assessed through the FIB-4 index.

    at 168th day post enrollment.

  • +41 more secondary outcomes

Study Arms (4)

Group A

EXPERIMENTAL

SOC+ Empagliflozin + Pioglitazone

Drug: Empagliflozin 10 MGDrug: Pioglitazone 15mgDrug: Metformin

Group B

EXPERIMENTAL

SOC +Empagliflozin

Drug: Empagliflozin 10 MGDrug: Metformin

Group C

EXPERIMENTAL

SOC+ Pioglitazone

Drug: Pioglitazone 15mgDrug: Metformin

Group D

ACTIVE COMPARATOR

SOC only

Drug: Metformin

Interventions

Empagliflozin 10 MGDRUG

10-25 mg/day

Group AGroup B
Pioglitazone 15mgDRUG

15-45 mg/day

Group AGroup C
MetforminDRUG

1000mg-2850mg/ day

Group AGroup BGroup CGroup D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • T2DM patients with NAFLD glycated
  • APRI scores of more than 1.5

You may not qualify if:

  • Patients having type 1 diabetes
  • evidence of advanced/decompensated cirrhosis (on the basis of a Child-Pugh score of more than 7 and MELD of more than 15)
  • hepatocellular carcinoma (evidence on ultrasound or alpha-fetoprotein)
  • patient suffering from acute or chronic hepatitis
  • biliary disease
  • HIV
  • hemochromatosis
  • autoimmune conditions (alpha-1 antitrypsin deficiency, autoimmune hepatitis, Wilson's disease)
  • renal dysfunction with GFR \[eGFR\] \<30 mL/min/1.73m2
  • history of alcohol ( male \>30 g/d and female;20 g/d)
  • history of cancer or undergoing treatment for cancer,
  • use of amiodarone, tamoxifen, sodium valproate, corticosteroids, methotrexate, ursodeoxycholic acid, S-adenosyl methionine, betaine, silymarin, gemfibrozil
  • using supplements including vitamin E, vitamin C, zinc, and selenium or antioxidant agents over the last 3 months
  • history of cardiovascular events within the past 3 months
  • pregnancy or breastfeeding
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical ICU, Jinnah Postgraduate Medical Centre

Karachi, Sindh, 71550, Pakistan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

empagliflozinPioglitazoneMetformin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 12, 2023

Study Start

October 1, 2023

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

July 12, 2023

Record last verified: 2023-07

Locations

PA(1)