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OpenTrials
Completed

NCT Number: NCT03380416

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

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.

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Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases NAFLD Non-alcoholic Fatty Liver Disease Nutritional and Metabolic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Medicine and Surgery

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Portfolio Diet

Other

Medium-term (8 weeks ) nutritional intervention

MUFA Diet

Other

Medium-term (8 weeks ) nutritional intervention used as control

Primary outcomes

  1. Liver fat content

    Time frame: Change from Baseline after 8 weeks

    MRI spectroscopy

Secondary outcomes

  1. Liver functionality

    Time frame: Change from Baseline after 8 weeks

    Liver enzymes

  2. Blood pressure

    Time frame: Change from Baseline after 8 weeks

  3. Endothelial function

    Time frame: Change from Baseline after 8 weeks

    Flow-mediated dilation

  4. Liver fibrosis

    Time frame: Change from Baseline after 8 weeks

    Transient Elastography

  5. Biochemical parameters

    Time frame: Change from Baseline after 8 weeks

    glucose homeostasis (glucose)

  6. Body composition

    Time frame: Change from Baseline after 8 weeks

    bioimpedance analyses (BIA)

  7. lipids

    Time frame: Change from Baseline after 8 weeks

  8. subclinical inflammation

    Time frame: Change from Baseline after 8 weeks

    elisa

  9. oxidative stress

    Time frame: Change from Baseline after 8 weeks

    urinary isoprostanes

  10. Biochemical parameters

    Time frame: Change from Baseline after 8 weeks

    glucose homeostasis (HbA1c)

  11. Biochemical parameters

    Time frame: Change from Baseline after 8 weeks

    glucose homeostasis (Insulin)

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Acronym: MEDEA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2017
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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