Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients
- Conditions
- NAFLDDiabetes Type 2
- Registration Number
- NCT03380416
- Lead Sponsor
- Federico II University
- Brief Summary
Patients with type 2 diabetes and non-alcoholic fatty liver disease will be enrolled.
According to a parallel design, the participants will be randomized to a Portfolio diet or a monounsaturated fatty acid (MUFA)-rich diet (used as control) for 8 weeks.
At the beginning and at the end of the trial, the participants will undergo a MRI spectroscopy to evaluate fatty liver content. Moreover, the participants will undergo a test meal resembling the nutritional composition of the assigned diet to evaluate fasting and postprandial metabolic response.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- type 2 diabetes
- non-alcoholic fatty liver disease (evaluated by US)
- HbA1c <7.5%
- LDL cholesterol <130 mg/dl
- hypoglycemic therapy with sodium-glucose cotransporter (SGLT-2), pioglitazone and glucagon-like peptide (GLP-1) analogues
- severe liver and kidney failure
- recent cardiovascular events (prior 6 months)
- any other acute/chronic disease (anemia, cancer, BPCO)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Liver fat content Change from Baseline after 8 weeks MRI spectroscopy
- Secondary Outcome Measures
Name Time Method Blood pressure Change from Baseline after 8 weeks Liver functionality Change from Baseline after 8 weeks Liver enzymes
Liver fibrosis Change from Baseline after 8 weeks Transient Elastography
Body composition Change from Baseline after 8 weeks bioimpedance analyses (BIA)
Endothelial function Change from Baseline after 8 weeks Flow-mediated dilation
Biochemical parameters Change from Baseline after 8 weeks glucose homeostasis (Insulin)
oxidative stress Change from Baseline after 8 weeks urinary isoprostanes
lipids Change from Baseline after 8 weeks subclinical inflammation Change from Baseline after 8 weeks elisa
Trial Locations
- Locations (1)
Department of Clinical Medicine and Surgery
🇮🇹Naples, Italy
Department of Clinical Medicine and Surgery🇮🇹Naples, Italy