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

• ClinicalTrials.gov Identifier: NCT01025856
• Recruitment Status: Completed
• First Posted: December 4, 2009
• Last Update Posted: December 5, 2012
• Sponsor: Federico II University
• Information provided by (Responsible Party): rivellese angela, Federico II University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
• Study Start Date: September 2009
• Actual Primary Completion Date: September 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Liver fat content [ Time Frame: 0 and 8 weeks ]
2. postprandial lipids metabolism [ Time Frame: 0 and 8 weeks ]

Secondary Outcome Measures :

1. changes in body fat distribution [ Time Frame: 0 and 8 weeks ]
2. oxidative stress and inflammation [ Time Frame: 0 and 8 weeks ]
3. adipose tissue lipolytic activities [ Time Frame: 0 and 8 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 35 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Bozzetto L, Costabile G, Luongo D, Naviglio D, Cicala V, Piantadosi C, Patti L, Cipriano P, Annuzzi G, Rivellese AA. Reduction in liver fat by dietary MUFA in type 2 diabetes is helped by enhanced hepatic fat oxidation. Diabetologia. 2016 Dec;59(12):2697-2701. Epub 2016 Sep 20.

Bozzetto L, Annuzzi G, Costabile G, Costagliola L, Giorgini M, Alderisio A, Strazzullo A, Patti L, Cipriano P, Mangione A, Vitelli A, Vigorito C, Riccardi G, Rivellese AA. A CHO/fibre diet reduces and a MUFA diet increases postprandial lipaemia in type 2 diabetes: no supplementary effects of low-volume physical training. Acta Diabetol. 2014;51(3):385-93. doi: 10.1007/s00592-013-0522-6. Epub 2013 Oct 17.

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. doi: 10.2337/dc12-0033.

• Responsible Party: rivellese angela, PA, Federico II University
• ClinicalTrials.gov Identifier: NCT01025856
• Other Study ID Numbers: 46/09
• First Posted: December 4, 2009
• Last Update Posted: December 5, 2012
• Last Verified: December 2012

Keywords provided by rivellese angela, 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