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

Federico II University

Status: Completed

Conditions: Postprandial Lipids Metabolism; Type 2 Diabetes

Treatments: Other: Rich in MUFA diet+PA; Other: Rich in MUFA diet -PA; Other: high fiber/low glycemic index diet + pa; Other: High fibre/low glycemic index diet-PA

Study type: Interventional

Funder types: Other

Identifiers

NCT01025856

46/09

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 4 patient groups

high fibre/low glycemic index diet - P A

Active Comparator group

Description:

patients will follow for two months a diet high fibre/low glycemic index without physical activity program

Treatment:

Other: High fibre/low glycemic index diet-PA

Rich in MUFA diet - PA

Active Comparator group

Description:

Patients will follow for two months a rich in MUFA diet without a physical activity program.

Treatment:

Other: Rich in MUFA diet -PA

high fibre/low glycemic index diet+PA

Active Comparator group

Description:

Patients will follow for two months a high fibre and low glycemic index diet associated with a physical activity program.

Treatment:

Other: high fiber/low glycemic index diet + pa

Rich in MUFA diet+PA

Active Comparator group

Description:

Patients will follow for 2 months a rich in MUFA diet with a physical activity program.

Treatment:

Other: Rich in MUFA diet+PA