← Back to Search

Insulin Sensitizer

Pioglitazone for Fatty Liver Disease

Phase 4

Recruiting

Led By Luke Norton, PhD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking any medication known to affect glucose metabolism other than antidiabetic medications

Age = 18-80 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 16

Awards & highlights

Study Summary

This trial is testing a diabetes drug to see if it can improve liver function in people with diabetes and fatty liver.

Who is the study for?

This trial is for adults aged 18-80 with Type 2 Diabetes and moderate to severe fatty liver disease, but not advanced fibrosis or cirrhosis. Participants should be in good health overall, have a BMI of 25-40 kg/m2, and an HbA1c level between 7-10%. They must be on stable diabetes treatment with diet, metformin, or sulfonylurea and not taking other glucose-affecting drugs.Check my eligibility

What is being tested?

The study tests the effects of pioglitazone (an insulin sensitizer) compared to a placebo on liver mitochondrial function in patients with Type 2 Diabetes who also have non-alcoholic fatty liver disease. The treatment period lasts for 16 weeks.See study design

What are the potential side effects?

Pioglitazone may cause side effects like fluid retention leading to swelling and weight gain, potential worsening of heart failure, increased risk of bone fractures especially in women, and possible increase in ovulation leading to pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am not on medication affecting blood sugar, except for diabetes treatment.

Select...

I am between 18 and 80 years old.

Select...

My liver has a lot of fat but little to no scarring.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect of pioglitazone on hepatic mitochondrial TCA cycle fluxes

Secondary outcome measures

Effect of pioglitazone on hepatic gene regulatory networks

Effect of pioglitazone on the hepatic lipidome

Examine the effect of pioglitazone on non-invasive markers of NAFLD

+5 more

Side effects data

From 2014 Phase 4 trial • 20 Patients • NCT01612858

19%

diarrhea

13%

Elevated lactic acid

13%

nausea

13%

Elevated serum creatinine

Bloating

Head trauma accompanied by syncope

vomiting

Baker's cyst

tooth pain

Right upper quadrant abdominal pain

Colitis

100%

80%

60%

40%

20%

Study treatment Arm

Metformin

Pioglitazone

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: NASH TZDExperimental Treatment1 Intervention

T2D with non-alcoholic steatohepatitis (NASH), treated with pioglitazone

Group II: NAFL TZDExperimental Treatment1 Intervention

T2D with non-alcoholic fatty liver (NAFL), treated with pioglitazone

Group III: NASH PlaceboPlacebo Group1 Intervention

T2D with non-alcoholic steatohepatitis (NASH), treated with placebo

Group IV: NAFL PlaceboPlacebo Group1 Intervention

T2D with non-alcoholic fatty liver (NAFL), treated with placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pioglitazone

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

453 Previous Clinical Trials

91,901 Total Patients Enrolled

1 Trials studying Non-alcoholic Fatty Liver Disease

55 Patients Enrolled for Non-alcoholic Fatty Liver Disease

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,365 Previous Clinical Trials

4,316,142 Total Patients Enrolled

46 Trials studying Non-alcoholic Fatty Liver Disease

9,970 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Luke Norton, PhDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

Media Library

Pioglitazone (Insulin Sensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT05305287 — Phase 4

Pioglitazone (Insulin Sensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05305287 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research investigation open to people younger than twenty-five?

"As per the regulations of this medical trial, all participants must be aged between 18 and 75 to qualify."

Answered by AI

What is the scope of subjects taking part in this investigation?

"Affirmative. According to clinicaltrials.gov, this research endeavor is actively engaging volunteers who meet the criteria for inclusion - initially posted on February 1st 2022 and last updated on October 19th of that same year. The trial aims to recruit a total of 60 patients from two different sites."

Answered by AI

Is it still possible for participants to join this research endeavor?

"Affirmative. Evidence hosted on clinicaltrials.gov validates that this experiment was initially advertised in February 2022 and the latest update was posted October 19th, 2022. The research is looking for 60 participants from two medical centres to participate."

Answered by AI

How might I participate in this research initiative?

"This medical experiment has room for 60 individuals suffering from type 2 diabetes mellitus, aged 18 to 75. Criteria of enrollment includes: T2D with NAFL, Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl), Treated with diet, metformin, and/or sulfonylurea and in good general health ascertained by medical history assessment, physical exam tests, and regular blood chemistries; age = 18-75 years; BMI = 25-40 kg/m2; HbA1c = 7-10%; steady body weight (±4 pounds) over"

Answered by AI