Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Who this trial is looking for
This trial is looking for people with type 2 diabetes and fatty liver disease. Participants will receive treatment with a medication called pioglitazone for 16 weeks to study its effects.
Are You a Good Fit for This Trial?
Must be takingMetformin
You may be able to join if
I have been diagnosed with type 2 diabetes.
I have fatty liver disease.
I am between 18 and 80 years old.
I have a stable body weight over the last 3 months.
I have a body mass index (BMI) between 25 and 40.
My HbA1c level is between 7% and 10%.
I am in good general health.
I am treating my diabetes with diet, metformin, or sulfonylurea.
You may not be able to join if
I drink more than 14 units of alcohol a week if I am a woman.
I drink more than 21 units of alcohol a week if I am a man.
I have liver cirrhosis.
I have another chronic liver disease.
I have type 1 diabetes.
I have proliferative retinopathy.
My urine albumin excretion is more than 300 mg per day.
I have a history of heart failure.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Trial Locations
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Status
Eligibility Criteria
T2D with NAFL
Inclusion Criteria:
* 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 = …
T2D with NAFL
Inclusion Criteria:
* 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).
Exclusion Criteria:
* 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 subjects.
* Subjects 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
T2D with NASH
Inclusion Criteria:
* 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% liver fat on MRI-PDFF) and moderate/severe hepatic fibrosis (grade F2/F3 on FibroScan).
Exclusion Criteria:
* 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 subjects.
* Subjects 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
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