Status:
ENROLLING_BY_INVITATION
Medium-term Effects of a Polyphenol-rich Beverage Based on Red Grape Pomace Extract on Non-alcoholic Fatty Liver Disease, Cardiometabolic Risk Profile and Gut Microbiota in Subjects with Type 2 Diabetes
Lead Sponsor:
Federico II University
Collaborating Sponsors:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Conditions:
Diabetes Mellitus Type 2
Eligibility:
MALE
35-70 years
Phase:
NA
Brief Summary
Nonalcoholic fatty liver disease (NAFLD) is a liver disease characterized by an abnormal accumulation of fat not due to alcohol or drug consumption that can evolve into steatohepatitis (NASH), fibrosi...
Detailed Description
A randomized, crossover, placebo-controlled study will be conducted. Twenty patients with type 2 diabetes mellitus (T2DM) recruited from the Diabetes Unit of the University Hospital of Naples "Federic...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) \>25 and ≤35 kg/m2
- Cholesterolemia ≤ 250 mg/dl and Triglyceridemia ≤ 200 mg/dl.
- type 2 Diabetes in good glycemic control (Hb1Ac ≤7.5%) treated with diet alone or diet + metformin.
Exclusion
- Cardiovascular events (myocardial infarction and/or stroke)
- Renal insufficiency (serum creatinine \>1.5 mg/dl) and liver failure (ALT/AST twice the normal values)
- Anemia (Hb \<12 g/dl) or other chronic disease
- Insulin therapy and other hypoglycemic drugs other than metformin
- Habitual intense physical activity
Key Trial Info
Start Date :
May 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06895018
Start Date
May 3 2024
End Date
October 31 2025
Last Update
March 26 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Federico II University
Napoli, Italy, 80131