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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
rivellese angela, Federico II University
ClinicalTrials.gov Identifier:
NCT01025856
First received: December 2, 2009
Last updated: December 3, 2012
Last verified: December 2012

December 2, 2009
December 3, 2012
September 2009
September 2011   (final data collection date for primary outcome measure)
  • Liver fat content [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • postprandial lipids metabolism [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01025856 on ClinicalTrials.gov Archive Site
  • changes in body fat distribution [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • oxidative stress and inflammation [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
  • adipose tissue lipolytic activities [ Time Frame: 0 and 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Postprandial Lipids Metabolism
  • Type 2 Diabetes
  • Other: Rich in MUFA diet -PA
    The patients will follow a rich in MUFA diet without a physical activity program.
  • Other: high fiber/low glycemic index diet + pa
    patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.
  • Other: Rich in MUFA diet+PA
    Patients will follow for two months a rich in MUFA diet with a physical activity program.
  • Other: High fibre/low glycemic index diet-PA
    Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.
  • Active Comparator: high fibre/low glycemic index diet - P A
    patients will follow for two months a diet high fibre/low glycemic index without physical activity program
    Intervention: Other: High fibre/low glycemic index diet-PA
  • Active Comparator: Rich in MUFA diet - PA
    Patients will follow for two months a rich in MUFA diet without a physical activity program.
    Intervention: Other: Rich in MUFA diet -PA
  • Active Comparator: high fibre/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.
    Intervention: Other: high fiber/low glycemic index diet + pa
  • Active Comparator: Rich in MUFA diet+PA
    Patients will follow for 2 months a rich in MUFA diet with a physical activity program.
    Intervention: Other: Rich in MUFA diet+PA

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
September 2011
September 2011   (final data collection date for primary outcome measure)

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).
Both
35 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01025856
46/09
No
rivellese angela, Federico II University
Federico II University
Not Provided
Not Provided
Federico II University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP