Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes

The aim of this study will be to evaluate in patients with type 2 diabetes the effects on liver fat of an intervention with a diet relatively rich in CHO/rich in fibre/low GI or a diet rich in MUFA, either combined or not with a structured program of physical exercise, with emphasis on mechanisms possibly underlining these effects, namely changes in postprandial triglyceride-rich lipoproteins, body fat distribution, insulin sensitivity, oxidative stress and inflammation, adipose tissue lipolytic activities, aerobic capacity and endothelial function.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes; Postprandial Lipids Metabolism
• Intervention / Treatment: Other: High fibre/low glycemic index diet-PA; Other: Rich in MUFA diet -PA; Other: high fiber/low glycemic index diet + pa; Other: Rich in MUFA diet+PA

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and postmenopausal women
• Age 35-65 years
• BMI 27- 34 kg/m2
• HbA1c <8%
• Fasting plasma cholesterol <250 mg/dl
• Fasting plasma triglycerides <300 mg/dl

Exclusion Criteria:

• Hypolipidemic drugs
• Plasma creatinine >1.7 mg/dl transaminases > 2 norma values
• Ischemic heart disease or positive treadmill stress test
• High intensity regular physical activity
• Any disease or chronic or/and acute condition contraindicating physical activity(anaemia, and infectious, neoplastic, neurological and osteoarticular diseases).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: high fibre/low glycemic index diet - P A; patients will follow for two months a diet high fibre/low glycemic index without physical activity program	Other: High fibre/low glycemic index diet-PA; Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.
Active Comparator: Rich in MUFA diet - PA; Patients will follow for two months a rich in MUFA diet without a physical activity program.	Other: Rich in MUFA diet -PA; The patients will follow a rich in MUFA diet without a physical activity program.
Active Comparator: high fibre/low glycemic index diet+PA; Patients will follow for two months a high fibre and low glycemic index diet associated with a physical activity program.	Other: high fiber/low glycemic index diet + pa; patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.
Active Comparator: Rich in MUFA diet+PA; Patients will follow for 2 months a rich in MUFA diet with a physical activity program.	Other: Rich in MUFA diet+PA; Patients will follow for two months a rich in MUFA diet with a physical activity program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Liver fat content	0 and 8 weeks
postprandial lipids metabolism	0 and 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
changes in body fat distribution	0 and 8 weeks
oxidative stress and inflammation	0 and 8 weeks
adipose tissue lipolytic activities	0 and 8 weeks

Collaborators and Investigators

• Sponsor: Federico II University

Publications and helpful links

General Publications

• Bozzetto L, Costabile G, Luongo D, Naviglio D, Cicala V, Piantadosi C, Patti L, Cipriano P, Annuzzi G, Rivellese AA. Reduction in liver fat by dietary MUFA in type 2 diabetes is helped by enhanced hepatic fat oxidation. Diabetologia. 2016 Dec;59(12):2697-2701. doi: 10.1007/s00125-016-4110-5. Epub 2016 Sep 20.
• Bozzetto L, Annuzzi G, Costabile G, Costagliola L, Giorgini M, Alderisio A, Strazzullo A, Patti L, Cipriano P, Mangione A, Vitelli A, Vigorito C, Riccardi G, Rivellese AA. A CHO/fibre diet reduces and a MUFA diet increases postprandial lipaemia in type 2 diabetes: no supplementary effects of low-volume physical training. Acta Diabetol. 2014;51(3):385-93. doi: 10.1007/s00592-013-0522-6. Epub 2013 Oct 17.
• Bozzetto L, Prinster A, Annuzzi G, Costagliola L, Mangione A, Vitelli A, Mazzarella R, Longobardo M, Mancini M, Vigorito C, Riccardi G, Rivellese AA. Liver fat is reduced by an isoenergetic MUFA diet in a controlled randomized study in type 2 diabetic patients. Diabetes Care. 2012 Jul;35(7):1429-35. doi: 10.2337/dc12-0033.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 3, 2009
• First Posted (Estimate): December 4, 2009

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 3, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: exercise; type 2 diabetes; diet; liver fat; postprandial lipids metabolism
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 46/09