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

Not Applicable

Completed

• Conditions: Postprandial Lipids Metabolism; Type 2 Diabetes
• Interventions: 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

• Registration Number: NCT01025856
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-03
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high fibre/low glycemic index diet - P A	High fibre/low glycemic index diet-PA	patients will follow for two months a diet high fibre/low glycemic index without physical activity program
Rich in MUFA diet - PA	Rich in MUFA diet -PA	Patients will follow for two months a rich in MUFA diet without a physical activity program.
high fibre/low glycemic index diet+PA	high fiber/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.
Rich in MUFA diet+PA	Rich in MUFA diet+PA	Patients will follow for 2 months a rich in MUFA diet with a physical activity program.

Primary Outcome Measures

Name	Time	Method
Liver fat content	0 and 8 weeks
postprandial lipids metabolism	0 and 8 weeks

Secondary Outcome Measures

Name	Time	Method
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