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

NCT ID: NCT01025856

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Postprandial Lipids Metabolism Type 2 Diabetes

Keywords

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liver fat postprandial lipids metabolism diet exercise type 2 diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

High fibre/low glycemic index diet-PA

Intervention Type OTHER

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

Rich in MUFA diet - PA

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

Group Type ACTIVE_COMPARATOR

Rich in MUFA diet -PA

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

high fiber/low glycemic index diet + pa

Intervention Type OTHER

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

Rich in MUFA diet+PA

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

Group Type ACTIVE_COMPARATOR

Rich in MUFA diet+PA

Intervention Type OTHER

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

Interventions

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Rich in MUFA diet -PA

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

Intervention Type 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.

Intervention Type OTHER

Rich in MUFA diet+PA

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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rivellese angela

PA

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 27650287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24132660 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22723581 (View on PubMed)

Other Identifiers

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46/09

Identifier Type: -

Identifier Source: org_study_id