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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01025856
Enrollment
45
Registered
2009-12-04
Start date
2009-09-30
Completion date
2011-09-30
Last updated
2012-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postprandial Lipids Metabolism, Type 2 Diabetes

Keywords

liver fat, postprandial lipids metabolism, diet, exercise, type 2 diabetes

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.

Interventions

OTHERRich in MUFA diet -PA

The patients will follow a rich in MUFA diet without a physical activity program.

OTHERhigh fiber/low glycemic index diet + pa

patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.

OTHERRich in MUFA diet+PA

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

OTHERHigh fibre/low glycemic index diet-PA

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

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Liver fat content0 and 8 weeks
postprandial lipids metabolism0 and 8 weeks

Secondary

MeasureTime frame
changes in body fat distribution0 and 8 weeks
oxidative stress and inflammation0 and 8 weeks
adipose tissue lipolytic activities0 and 8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026