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Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients

Not Applicable
Completed
Conditions
NAFLD
Diabetes 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
Inclusion Criteria
  • type 2 diabetes
  • non-alcoholic fatty liver disease (evaluated by US)
  • HbA1c <7.5%
  • LDL cholesterol <130 mg/dl
Exclusion Criteria
  • 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
NameTimeMethod
Liver fat contentChange from Baseline after 8 weeks

MRI spectroscopy

Secondary Outcome Measures
NameTimeMethod
Blood pressureChange from Baseline after 8 weeks
Liver functionalityChange from Baseline after 8 weeks

Liver enzymes

Liver fibrosisChange from Baseline after 8 weeks

Transient Elastography

Body compositionChange from Baseline after 8 weeks

bioimpedance analyses (BIA)

Endothelial functionChange from Baseline after 8 weeks

Flow-mediated dilation

Biochemical parametersChange from Baseline after 8 weeks

glucose homeostasis (Insulin)

oxidative stressChange from Baseline after 8 weeks

urinary isoprostanes

lipidsChange from Baseline after 8 weeks
subclinical inflammationChange from Baseline after 8 weeks

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Trial Locations

Locations (1)

Department of Clinical Medicine and Surgery

🇮🇹

Naples, Italy

Department of Clinical Medicine and Surgery
🇮🇹Naples, Italy

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