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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postprandial Lipids Metabolism, Type 2 Diabetes

Intervention / Treatment
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* Other: Rich in MUFA diet -PA
* Other: high fiber/low glycemic index diet + pa
* Other: Rich in MUFA diet+PA
* Other: High fibre/low glycemic index diet-PA


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: high fibre/low glycemic index diet - P A<br>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<br>* Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.<br>|
| Active Comparator: Rich in MUFA diet - PA<br>Patients will follow for two months a rich in MUFA diet without a physical activity program. | Other: Rich in MUFA diet -PA<br>* The patients will follow a rich in MUFA diet without a physical activity program.<br>|
| Active Comparator: high fibre/low glycemic index diet+PA<br>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<br>* patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.<br>|
| Active Comparator: Rich in MUFA diet+PA<br>Patients will follow for 2 months a rich in MUFA diet with a physical activity program. | Other: Rich in MUFA diet+PA<br>* Patients will follow for two months a rich in MUFA diet with a physical activity program.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver fat, postprandial lipids metabolism, diet, exercise, type 2 diabetes