Quantifying Hepatic Mitochondrial Fluxes in Humans
Recruiting · San Antonio, Texas
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Study care at no cost to you
For your time and travel
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Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Adults age 18–80 with confirmed type 2 diabetes based on an OGTT (2-hour glucose ≥200 mg/dl).
- •People with BMI 25–40 kg/m².
- •People with HbA1c 7–10% who have a stable body weight for the last 3 months (within ±4 pounds).
- •People who have moderate to severe fatty liver on FibroScan (steatosis grade S2/S3).
- •People willing to be treated with diet and/or metformin and/or sulfonylurea and otherwise in good general health based on routine checks.
🚫 You may not be able to join if…
- •People who drink alcohol above the limits: more than 14 units/week for women or more than 21 units/week for men.
- •People with cirrhosis (Fibrosis stage 4) or with liver scarring stage F2/F3 are excluded in the NAFL group (NASH group requires F2/F3).
- •People with type 1 diabetes and/or positive GAD.
- •People who are not “drug naive,” or who have been on metformin for more than 3 months.
- •People with NY Class III–IV heart failure, proliferative retinopathy, or urine albumin excretion >300 mg/day.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–80
- ✓Have Obesity / overweight or Fatty liver disease (NASH/MASH)
- !Some conditions may not be a fit: Heart / cardiovascular disease, Anxiety
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
In this study the investigators will quantitate hepatic mitochondrial fluxes in T2D patients with NAFL and NASH before and after 16-weeks treatment with the insulin sensitizer pioglitazone
Is it safe? Who makes sure of that?+
This is a study of an already-approved treatment (Phase 4). Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT05305287 · Locations: Texas