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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025856
• Other study ID #: 46/09
• Status: Completed
• Phase: N/A
• First received: December 2, 2009
• Last updated: December 3, 2012
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: December 2012
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Postprandial Lipids Metabolism
• Type 2 Diabetes

Intervention

Other:
• Rich in MUFA diet -PA
The patients will follow a rich in MUFA diet without a physical activity program.
• 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.
• Rich in MUFA diet+PA
Patients will follow for two months a rich in MUFA diet with a physical activity program.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver fat content		0 and 8 weeks	No
Primary	postprandial lipids metabolism		0 and 8 weeks	No
Secondary	changes in body fat distribution		0 and 8 weeks	No
Secondary	oxidative stress and inflammation		0 and 8 weeks	No
Secondary	adipose tissue lipolytic activities		0 and 8 weeks	No