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

NCT01025856 | Completed

• 1 other identifier: 46/09
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postprandial Lipids Metabolism; Type 2 Diabetes

Keywords

liver fat; postprandial lipids metabolism; diet; exercise; type 2 diabetes

Outcome Measures

Primary Outcomes (2)

• Liver fat content

  0 and 8 weeks

• postprandial lipids metabolism

  0 and 8 weeks

Secondary Outcomes (3)

• 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

Study Arms (4)

high fibre/low glycemic index diet - P A

ACTIVE COMPARATOR

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

Rich in MUFA diet - PA

ACTIVE COMPARATOR

Patients will follow for two months a rich in MUFA diet without a physical activity program.

Other: Rich in MUFA diet -PA

high fibre/low glycemic index diet+PA

ACTIVE COMPARATOR

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

Rich in MUFA diet+PA

ACTIVE COMPARATOR

Patients will follow for 2 months a rich in MUFA diet with a physical activity program.

Other: Rich in MUFA diet+PA

Interventions

Rich in MUFA diet -PA OTHER

The patients will follow a rich in MUFA diet without a physical activity program.

Rich in MUFA diet - PA

high fiber/low glycemic index diet + pa OTHER

patients will follow for two months a high fibre/ low glycemic index diet with a physical activity program.

high fibre/low glycemic index diet+PA

Rich in MUFA diet+PA OTHER

Patients will follow for two months a rich in MUFA diet with a physical activity program.

Rich in MUFA diet+PA

High fibre/low glycemic index diet-PA OTHER

Patients will follow for two months a high fibre/low glycemic index diet without a physical activity program.

high fibre/low glycemic index diet - P A

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Federico II University: lead

Related Publications (3)

• 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. doi: 10.1007/s00125-016-4110-5. Epub 2016 Sep 20.

  PMID: 27650287 DERIVED

• 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.

  PMID: 24132660 DERIVED

• 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.

  PMID: 22723581 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Fatty Liver; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Liver Diseases; Digestive System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PA

Study Record Dates

• First Submitted: December 2, 2009
• First Posted: December 4, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: December 5, 2012

Record last verified: 2012-12