A Phase 4 interventional study of Empagliflozin 10 MG and Pioglitazone 15mg in Non-Alcoholic Fatty Liver Disease and Type2diabetes, sponsored by Jinnah Postgraduate Medical Centre. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Jinnah Postgraduate Medical Centre · Phase 4, Interventional, and Treatment
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.
This is a randomized clinical trial conducted to compare the efficacies of pioglitazone and empagliflozin in people suffering from NAFLD associated with T2DM.
Randomization will be done using card randomization. Four different color-coded cards will be kept. Any card will be randomly picked for the patient fulfilling inclusion criteria and will be treated according to the allocated treatment arm mentioned on the card
Written informed consent will be obtained from the immediate attendant of the patient. All ethical considerations will be followed.
Our research has been approved by Jinnah Sindh Medical University, Karachi. For this approval, the investigators have made every effort to ensure the confidentiality of research data collected from all our participants in this survey. The information collected will be stored with the investigators only in the form of de-identified information and will be retained in a secure place under lock and key. Any results that will be generated will be presented on a collective basis, and will not contain the participants name or any other personal details.
Data entry and analysis will be done using SPSS Software version 23. Study analysis will be done using the principle of intention to treat. The mean scores will be compared pre and post-intervention using paired t-test. The association of age, gender, and grade of fatty liver will be compared with different groups using correlation and regression models. All analyses will be at a confidence Interval of 95% and a p-value \<.05.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 240 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Jinnah Postgraduate Medical Centre is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SOC+ Empagliflozin + Pioglitazone
Drug: Empagliflozin 10 MG · Drug: Pioglitazone 15mg · Drug: Metformin
SOC +Empagliflozin
Drug: Empagliflozin 10 MG · Drug: Metformin
SOC+ Pioglitazone
Drug: Pioglitazone 15mg · Drug: Metformin
SOC only
Drug: Metformin
10-25 mg/day
15-45 mg/day
1000mg-2850mg/ day
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.
Time frame: 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.
Time frame: Will be assessed at 168th day post enrollment.
change in SF-36 scores
36-Item Short Form Survey (SF-36) assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. A higher score defines a more favorable health state.
Time frame: Quality of life will be assessed 84th day post enrollment.
change in SF-36 scores
36-Item Short Form Survey (SF-36) assesses eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. A higher score defines a more favorable health state.
Time frame: Quality of life will be assessed at day 252 post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Time frame: at enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Time frame: 84th day post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Time frame: at 168th day post enrollment.
change in liver fibrosis will be assessed through the FIB-4 index.
Fibrosis-4 index (FIB-4). Low scores will indicate better outcomes (less fibrosis).
Time frame: at day 252 post enrollment.
change in liver fibrosis will be assessed through the APRI Score
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Time frame: at enrollment.
change in liver fibrosis will be assessed through the APRI Score
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Time frame: 84th day post enrollment.
change in liver fibrosis will be assessed through the APRI Score
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Time frame: at 168th day post enrollment.
change in liver fibrosis will be assessed through the APRI Score.
AST to platelet ratio index (APRI) Score. Lower the value better the outcome (less fibrosis)
Time frame: at day 252 post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Time frame: at enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Time frame: at 84th day post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Time frame: at 168th day post enrollment.
change in liver fibrosis will be assessed through the NFS Score.
NAFLD fibrosis score (NFS). Lower the value better the outcome (less fibrosis)
Time frame: at day 252 post enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Time frame: at enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Time frame: at 84th day post enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Time frame: at 168th day post enrollment.
Change in hepatic steatosis through the FLI score.
Fatty liver index (FLI). Lower the value better the outcome
Time frame: at day 252 post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome.
Time frame: at enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome.
Time frame: at 84th day post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome
Time frame: at 168th day post enrollment.
Change in Insulin resistance will be assessed through HOMA-2IR/IR scale.
homeostatic model assessment-2IR (HOMA-2IR/IR). The lower the value better the outcome.
Time frame: at day 252 post enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Time frame: At enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Time frame: 84th day post enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Time frame: at 168th day post enrollment.
Change in the LFT.
Liver Function test (LFT) such as alanine transaminase, aspartate transaminase, bilirubin, albumin, alkaline phosphatase, gamma-glutamyl transferase .
Time frame: at day 252 post enrollment.
Change in weight
weight. lower the levels better the outcome.
Time frame: at enrollment.
Change in weight
weight. lower the levels better the outcome.
Time frame: at 84th day post enrollment.
Change in weight
weight. lower the levels better the outcome.
Time frame: at 168th day post enrollment.
Change in weight
weight. lower the levels better the outcome.
Time frame: at day 252 post enrollment.
Change in random blood sugar
random blood sugar
Time frame: at enrollment.
Change in random blood sugar
random blood sugar.
Time frame: at 84th day post enrollment.
Change in random blood sugar
random blood sugar.
Time frame: at 168th day post enrollment.
Change in random blood sugar
random blood sugar. lower the levels better the outcome.
Time frame: at day 252 post enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Time frame: at enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Time frame: at 84th day post enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Time frame: at 168th day post enrollment.
Change in waist circumference
waist circumference. lower the levels better the outcome.
Time frame: at day 252 post enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Time frame: at enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Time frame: at 84th day post enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Time frame: at 168th day post enrollment.
Change in HbA1c
hemoglobin A1c (HbA1c).lower the levels better the outcome.
Time frame: at day 252 post enrollment.
Change in Body mass index
Body mass index. lower the levels better the outcome.
Time frame: at enrollment.
Change in body mass index
body mass index. lower the levels better the outcome.
Time frame: at 84th day post enrollment.
Change in body mass index
body mass index. lower the levels better the outcome.
Time frame: at 168th day post enrollment.
Change in body mass index
body mass index. lower the levels better the outcome.
Time frame: at day 252 post enrollment.
This study is not yet recruiting, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Jinnah Postgraduate Medical Centre