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

Tracking Information
First Received Date ^ICMJE	December 2, 2009
Last Updated Date	December 3, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 3, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01025856 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 3, 2009)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
Official Title ^ICMJE	Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Postprandial Lipids Metabolism Type 2 Diabetes
Intervention ^ICMJE	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.
Study Arm (s)	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
Publications *	Bozzetto L, Prinster A, Annuzzi G, Costagliola L, Mangione A, Vitelli A, Mazzarella R, Longobardo M, Mancini M, Vigorito C, Riccardi G, Rivellese AA. Liver fat is reduced by an isoenergetic MUFA diet in a controlled randomized study in type 2 diabetic patients. Diabetes Care. 2012 Jul;35(7):1429-35. PubMed PMID: 22723581; PubMed Central PMCID: PMC3379578.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	September 2011
Primary Completion Date	September 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	35 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01025856
Other Study ID Numbers ^ICMJE	46/09
Has Data Monitoring Committee	No
Responsible Party	rivellese angela, Federico II University
Study Sponsor ^ICMJE	Federico II University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Federico II University
Verification Date	December 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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