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Thiazolidinedione
Low-Dose Pioglitazone for NASH
Phase 2
Recruiting
Led By Kenneth Cusi, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 21 to 75 years
Patients with glycosylated hemoglobin (HbA1c) ≤ 9.5% on diet alone or on a stable dose of specified diabetes medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights
Study Summary
This trial will test the effects of a low dose of the drug pioglitazone on patients with type 2 diabetes and NASH.
Who is the study for?
This trial is for adults aged 21-75 with Type 2 Diabetes and biopsy-proven nonalcoholic steatohepatitis (NASH). Participants must have certain blood cell counts, liver function tests within specific limits, controlled diabetes (HbA1c ≤ 9.5%), and not be on medications affecting glucose tolerance or have other liver diseases. Pregnant women, heavy alcohol users, those with recent malignancies or heart disease are excluded.Check my eligibility
What is being tested?
The study aims to test the safety and effectiveness of a low-dose pioglitazone treatment (15 mg daily) compared to a placebo in improving liver health for patients with NASH who also have Type 2 Diabetes. The participants will either receive the actual medication or a placebo without knowing which one they are taking.See study design
What are the potential side effects?
Pioglitazone may cause fluid retention leading to swelling and weight gain, increase risk of bone fractures especially in women, and could potentially worsen diabetic eye disease. It's also linked to bladder cancer risk when used long-term at higher doses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 75 years old.
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My HbA1c level is 9.5% or lower, and I manage it with diet or stable diabetes medication.
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I have been diagnosed with Type 2 Diabetes.
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I can understand and communicate about the study, and I can legally consent.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of pioglitazone-treated patients relative to placebo achieving an improvement of ≥2 points in non-alcoholic fatty liver disease activity score (NAS) without an increase in fibrosis stage.
Secondary outcome measures
Fibrosis improvement.
Improvement of fibrosis AND resolution of NASH as a composite endpoint.
Improvement of fibrosis by at least 2 stages.
+9 moreOther outcome measures
Adipose tissue insulin sensitivity (Adipo-IR)
Atlas imaging
CAP (controlled attenuation parameter) and vibration controlled transient elastography (VCTE)
+7 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: PioglitazoneActive Control1 Intervention
Two arm, randomized, double-blind, placebo-controlled, 72 week treatment study receiving pioglitazone 15mg/day.
Group II: PlaceboPlacebo Group1 Intervention
Two arm, randomized, double-blind, placebo-controlled, 72 week treatment study receiving placebo.
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,539 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
516 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,908 Total Patients Enrolled
46 Trials studying Non-alcoholic Fatty Liver Disease
9,806 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Kenneth Cusi, MDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
183 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
183 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a form of diabetes that is not type 2.I have had cancer in the last 5 years, except for non-dangerous skin cancer which is cured.I am between 21 and 75 years old.I do not have uncontrolled high blood pressure, recent strokes, severe lung or kidney disease.I have a history of bladder issues or blood in my urine not caused by a recent UTI.Your blood tests need to show a certain level of hemoglobin, white blood cells, neutrophils, and platelets. Your albumin, creatinine, INR, bilirubin, AST, and ALT levels also need to be within specific ranges.My HbA1c level is 9.5% or lower, and I manage it with diet or stable diabetes medication.My chronic liver disease is not due to NASH.I am taking vitamin E, pioglitazone, or an FDA-approved NASH drug.I have a medical condition that causes fatty liver disease.I have been exposed to chemicals like carbon tetrachloride.I have been on IV nutrition in the last 6 months.I am taking medication that could cause fatty liver.I have had or am scheduled for weight loss surgery.I do not have signs of severe liver disease or cirrhosis.I've been on stable medication for over 4 weeks that may affect blood sugar levels.I consume more than the recommended amount of alcohol daily.I have been diagnosed with Type 2 Diabetes.I can understand and communicate about the study, and I can legally consent.I have a history of serious heart problems.I have a bleeding disorder or am currently on blood thinners.
Research Study Groups:
This trial has the following groups:- Group 1: Pioglitazone
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical trial accessible to geriatric populations?
"The investigators are seeking participants aged 21 and older, but under 75 years of age."
Answered by AI
Could I potentially participate in this research endeavor?
"To be eligible to partake in this medical study, prospective patients must have a diagnosis of type 2 diabetes mellitus and lie between 21-75 years old. The research group is currently looking for 166 participants."
Answered by AI
How many participants have been recruited for this research?
"Affirmative. The clinical trial repository hosts information on this investigation, which was launched on December 15th 2020 and lastly edited September 15th 2022. This study is presently welcoming 166 patients across a single medical centre."
Answered by AI
Has the FDA sanctioned Pioglitazone for public use?
"The safety of pioglitazone was deemed a 2 on the scale due to existing evidence in Phase 2 trials that provide some assurance of its security, but no clinical data yet available for efficacy."
Answered by AI
Are individuals still being accepted to join this trial?
"Affirmative, the data hosted on clinicaltrials.gov suggests that this trial is currently recruiting patients. It was initially posted on December 15th 2020 and has been updated as recently as September 15th 2022. The medical study requires 166 participants to be recruited from a single location."
Answered by AI
What medical conditions are typically treated with Pioglitazone?
"Through the aid of Pioglitazone, diabetes, diabetic neuralgia and dietary complications can be effectively managed."
Answered by AI
Has Pioglitazone been used for any other research purposes?
"At the moment, 31 clinical trials involving Pioglitazone are being conducted. Of these studies, 4 have reached phase 3. Most of them take place in Lausanne, Vaud; however, a total of 69 sites worldwide support the research into this drug's efficacy and safety."
Answered by AI
Recent research and studies
JHEP ReportsJournal
From NASH to Diabetes and from Diabetes to NASH: Mechanisms and Treatment OptionsOther Trials to Consider
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