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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
History of Changes
  Purpose

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.


Condition Intervention
Postprandial Lipids Metabolism
Type 2 Diabetes
 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federico II University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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: Rich in MUFA diet - PA
Patients will follow for two months a rich in MUFA diet without a physical activity program.
 Other: Rich in MUFA diet -PA
The patients will follow a rich in MUFA diet without a physical activity program.
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.
 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.
Active Comparator: Rich in MUFA diet+PA
Patients will follow for 2 months a rich in MUFA 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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Federico II University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: rivellese angela, PA, Federico II University
ClinicalTrials.gov Identifier: NCT01025856     History of Changes
Other Study ID Numbers: 46/09
Study First Received: December 2, 2009
Last Updated: December 3, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Federico II University:
liver fat
postprandial lipids metabolism
diet
exercise
type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013