Effect of Low-Dose Pioglitazone in Patients With Nonalcoholic Steatohepatitis (NASH)
University of Florida
Summary
To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
Description
Rationale: Several studies have shown that pioglitazone, at either 30 to 45 mg per day, is safe and effective in randomized, controlled trials (RCTs) of 6- to 24-month duration (Belfort et al, NEJM 2006; Aithal et al, Gastroenterology 2008; Sanyal et al, NEJM 2010; Cusi et al, Annals Int Med 2016; Bril et al, Diabetes Care 2019). However, pioglitazone has shown to also improve glucose and lipid metabolism at the lower dose of 15 mg per day in patients with type 2 diabetes (Aronoff et al, Diabetes Care 2000; Miyazaki et al, Diabetes Care 2002; Rosenstock et al, Int J Clin Pract. 2002; Rajagopal…
Eligibility
- Age range
- 21–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Able to communicate meaningfully with the investigator and legally competent to provide written informed consent. 2. Aged 21 to 75 years. 3. Patients with a diagnosis T2DM based on prior medical history, medication use, or results from a fasting plasma glucose or hemoglobin A1c, according to American Diabetes Association guidelines. 4. Patients will be allowed to participate the glycosylated hemoglobin (HbA1c) is ≤ 9.5% on diet alone or on a stable dose (for at least 2 months) of the following diabetes medications: metformin, sulfonylurea, acarbose, DPP-IV inhibitors, S…
Interventions
- DrugPioglitazone
An insulin-sensitizer FDA-approved to treat hyperglycemia caused by type 2 diabetes.
- OtherPlacebo
Placebo looks just like pioglitazone and is given in the same way but has no active drug in it.
Location
- University of FloridaGainesville, Florida