Clinical trial NCT01025856: Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
Official title: Combined Nutritional and Exercise Strategies to Reduce Liver Fat Content in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Lipids Metabolism
Type 2 Diabetes
Keywords: liver fat
postprandial lipids metabolism
diet
exercise
type 2 diabetes
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2009-12-04
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Liver fat content
timeFrame: 0 and 8 weeks
measure: postprandial lipids metabolism
timeFrame: 0 and 8 weeks
Secondary outcomes:
measure: changes in body fat distribution
timeFrame: 0 and 8 weeks
measure: oxidative stress and inflammation
timeFrame: 0 and 8 weeks
measure: adipose tissue lipolytic activities
timeFrame: 0 and 8 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.