NCT05305287 Quantifying Hepatic Mitochondrial Fluxes in Humans
| NCT ID | NCT05305287 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Non-Alcoholic Fatty Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 60 participants in total. It began in 2022-11-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 = 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. * Cirrhosis (fibrosis stage 4). * 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. * 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. * 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. * Cirrhosis (fibrosis stage 4). * 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. * 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. * History of NY Class III-IV heart failure
Contact & Investigator
Luke Norton, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT05305287 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non-Alcoholic Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05305287 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05305287 currently recruiting?
Yes, NCT05305287 is actively recruiting participants. Contact the research team at nortonl@uthscsa.edu for enrollment information.
Where is the NCT05305287 trial being conducted?
This trial is being conducted at San Antonio, United States, San Antonio, United States.
Who is sponsoring the NCT05305287 clinical trial?
NCT05305287 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Luke Norton, PhD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 60 participants.