Clinical trial NCT03380416: Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients
Official title: Medium-term Effects of a Portfolio Diet on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
NAFLD
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 49
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Liver fat content
timeFrame: Change from Baseline after 8 weeks
Secondary outcomes:
measure: Liver functionality
timeFrame: Change from Baseline after 8 weeks
measure: Blood pressure
timeFrame: Change from Baseline after 8 weeks
measure: Endothelial function
timeFrame: Change from Baseline after 8 weeks
measure: Liver fibrosis
timeFrame: Change from Baseline after 8 weeks
measure: Biochemical parameters
timeFrame: Change from Baseline after 8 weeks
measure: Body composition
timeFrame: Change from Baseline after 8 weeks
measure: lipids
timeFrame: Change from Baseline after 8 weeks
measure: subclinical inflammation
timeFrame: Change from Baseline after 8 weeks
measure: oxidative stress
timeFrame: Change from Baseline after 8 weeks
measure: Biochemical parameters
timeFrame: Change from Baseline after 8 weeks
measure: Biochemical parameters
timeFrame: Change from Baseline after 8 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Clinical Medicine and Surgery
Study officials:
References:
citation: Della Pepa G, Brancato V, Costabile G, Salamone D, Corrado A, Vitale M, Cavaliere C, Mancini M, Salvatore M, Luongo D, Riccardi G, Rivellese AA, Annuzzi G, Bozzetto L. An Isoenergetic Multifactorial Diet Reduces Pancreatic Fat and Increases Postprandial Insulin Response in Patients With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2022 Sep 1;45(9):1935-1942. doi: 10.2337/dc22-0605.
citation: Costabile G, Della Pepa G, Salamone D, Luongo D, Naviglio D, Brancato V, Cavaliere C, Salvatore M, Cipriano P, Vitale M, Corrado A, Rivellese AA, Annuzzi G, Bozzetto L. Reduction of De Novo Lipogenesis Mediates Beneficial Effects of Isoenergetic Diets on Fatty Liver: Mechanistic Insights from the MEDEA Randomized Clinical Trial. Nutrients. 2022 May 23;14(10):2178. doi: 10.3390/nu14102178.
citation: Della Pepa G, Vetrani C, Brancato V, Vitale M, Monti S, Annuzzi G, Lombardi G, Izzo A, Tommasone M, Cipriano P, Clemente G, Mirabelli P, Mancini M, Salvatore M, Riccardi G, Rivellese AA, Bozzetto L. Effects of a multifactorial ecosustainable isocaloric diet on liver fat in patients with type 2 diabetes: randomized clinical trial. BMJ Open Diabetes Res Care. 2020 May;8(1):e001342. doi: 10.1136/bmjdrc-2020-001342.