Non-Alcoholic Fatty Liver Disease study: Pioglitazone
Official title Quantifying Hepatic Mitochondrial Fluxes in Humans
ClinicalTrials.gov ID: NCT05305287
What this study is testing
What is Pioglitazone?
an investigational oral tablet being studied as a potential treatment for non‑alcoholic fatty liver disease (NAFLD) is designed to improve insulin sensitivity by activating the PPARγ receptor
Also referred to as Actos.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether 16 weeks of pioglitazone changes liver mitochondrial activity in people with type 2 diabetes and non‑alcoholic fatty liver disease or NASH.
- Who it's for
- You may be able to join if you have type 2 diabetes and non‑alcoholic fatty liver disease or NASH.
- What's involved
- You will take pioglitazone pills for 16 weeks. You will have tests to measure liver function before and after the treatment.
- Time commitment
- The study lasts about 4 months with visits at the start and end.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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 determined by medical history, physical exam, and routine blood...
- age = 18-80 years;
- BMI = 25-40 kg/m2;
You likely can't join if
- Alcohol consumption \>14 units/week for women and \>21 units/week for men.
- Liver cirrhosis (fibrosis stage 4).
- Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected/proven...
- Type 1 diabetes and/or GAD positive people.
- people not drug naive or have been on metformin more than 3 months.
- Presence of proliferative retinopathy.
See the full eligibility criteria
- 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 determined by medical history, physical exam, and routine blood chemistries;
- age = 18-80 years;
- BMI = 25-40 kg/m2;
- HbA1c = 7-10%; stable body weight (±4 pounds) over the preceding 3-months;
- not taking any medication known to affect glucose metabolism other than antidiabetic medications.
- Evidence of moderate/severe fatty liver (steatosis; grade S2/S3 on FibroScan corresponding to ≥10% fat on MRI-PDFF) and no/minimal hepatic fibrosis (grade F0/F1 on FibroScan).
- Alcohol consumption \>14 units/week for women and \>21 units/week for men.
- Liver cirrhosis (fibrosis stage 4).
- Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected/proven liver cancer and any other liver disease other than NAFLD.
- Type 1 diabetes and/or GAD positive people.
- people not drug naive or have been on metformin more than 3 months.
- Presence of proliferative retinopathy.
- Urine albumin excretion \> 300 mg/day.
- Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl).
- Treated with diet, metformin, and/or sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;
- age = 18-80 years;
- BMI = 25-40 kg/m2;
- HbA1c = 7-10%;
- stable body weight (±4 pounds) over the preceding 3-months;
- not taking any medication known to affect glucose metabolism other than antidiabetic medications.
- Alcohol consumption \>14 units/week for women and \>21 units/week for men.
- Liver cirrhosis (fibrosis stage 4).
- Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected/proven liver cancer and any other liver disease other than NAFLD.
- Type 1 diabetes and/or GAD positive people.
- people not drug naive or have been on metformin more than 3 months.
- Presence of proliferative retinopathy.
- Urine albumin excretion \> 300 mg/day.
- History of NY Class III-IV heart failure
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.