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

F

Federico II University

Status

Completed

Conditions

Postprandial Lipids Metabolism
Type 2 Diabetes

Treatments

Other: Rich in MUFA diet+PA
Other: Rich in MUFA diet -PA
Other: high fiber/low glycemic index diet + pa
Other: High fibre/low glycemic index diet-PA

Study type

Interventional

Funder types

Other

Identifiers

NCT01025856
46/09

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

45 participants in 4 patient groups

high fibre/low glycemic index diet - P A
Active Comparator group
Description:
patients will follow for two months a diet high fibre/low glycemic index without physical activity program
Treatment:
Other: High fibre/low glycemic index diet-PA
Rich in MUFA diet - PA
Active Comparator group
Description:
Patients will follow for two months a rich in MUFA diet without a physical activity program.
Treatment:
Other: Rich in MUFA diet -PA
high fibre/low glycemic index diet+PA
Active Comparator group
Description:
Patients will follow for two months a high fibre and low glycemic index diet associated with a physical activity program.
Treatment:
Other: high fiber/low glycemic index diet + pa
Rich in MUFA diet+PA
Active Comparator group
Description:
Patients will follow for 2 months a rich in MUFA diet with a physical activity program.
Treatment:
Other: Rich in MUFA diet+PA

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems