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

NAFLD Clinical Trial

— MEDEA  

Official title:

Medium-term Effects of a Portfolio Diet on Non-alcoholic Fatty Liver Disease in Type 2 Diabetic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380416
• Other study ID #: 16/17
• Status: Completed
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: March 2020
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 20, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2
• NAFLD

Intervention

Other:
• Portfolio Diet
Medium-term (8 weeks ) nutritional intervention
• MUFA Diet
Medium-term (8 weeks ) nutritional intervention used as control

Locations

Country	Name	City	State
Italy	Department of Clinical Medicine and Surgery	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fat content	MRI spectroscopy	Change from Baseline after 8 weeks
Secondary	Liver functionality	Liver enzymes	Change from Baseline after 8 weeks
Secondary	Blood pressure		Change from Baseline after 8 weeks
Secondary	Endothelial function	Flow-mediated dilation	Change from Baseline after 8 weeks
Secondary	Liver fibrosis	Transient Elastography	Change from Baseline after 8 weeks
Secondary	Biochemical parameters	glucose homeostasis (glucose)	Change from Baseline after 8 weeks
Secondary	Body composition	bioimpedance analyses (BIA)	Change from Baseline after 8 weeks
Secondary	lipids		Change from Baseline after 8 weeks
Secondary	subclinical inflammation	elisa	Change from Baseline after 8 weeks
Secondary	oxidative stress	urinary isoprostanes	Change from Baseline after 8 weeks
Secondary	Biochemical parameters	glucose homeostasis (HbA1c)	Change from Baseline after 8 weeks
Secondary	Biochemical parameters	glucose homeostasis (Insulin)	Change from Baseline after 8 weeks