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Clinical Trials/NCT01025856
NCT01025856
Completed
Not Applicable

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

Federico II University0 sites45 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postprandial Lipids Metabolism
Sponsor
Federico II University
Enrollment
45
Primary Endpoint
Liver fat content
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
September 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

rivellese angela

PA

Federico II University

Eligibility Criteria

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).

Outcomes

Primary Outcomes

Liver fat content

Time Frame: 0 and 8 weeks

postprandial lipids metabolism

Time Frame: 0 and 8 weeks

Secondary Outcomes

  • 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)

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