Skip to main content
OpenTrials
Completed

NCT Number: NCT01025856

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postprandial Lipids Metabolism Behavior Diabetes Mellitus Diabetes Mellitus, Type 2 Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Liver Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Rich in MUFA diet -PA

Other

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

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.

Rich in MUFA diet+PA

Other

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

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.

Primary outcomes

  1. Liver fat content

    Time frame: 0 and 8 weeks

  2. postprandial lipids metabolism

    Time frame: 0 and 8 weeks

Secondary outcomes

  1. changes in body fat distribution

    Time frame: 0 and 8 weeks

  2. oxidative stress and inflammation

    Time frame: 0 and 8 weeks

  3. adipose tissue lipolytic activities

    Time frame: 0 and 8 weeks

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 4, 2009
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.