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NCT Number: NCT01038102

Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance

The purpose of this study is to investigate whether substituting saturated fats with polyunsaturated fats reduces fatty liver and improves insulin action and other metabolic variables in abdominally obese subjects

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Key information

Conditions

Obesity Body Weight Diabetes Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University Hospital, Uppsala Science Park

Uppsala, 75185, Sweden

About this study

Specific goals:

  • Investigate if substituting saturated fats with polyunsaturated fats reduces steatosis and improves hepatic and/or peripheral insulin action in abdominally obese subjects with type 2 diabetes
  • Investigate if changes of lipogenic enzymes in response to dietary fat intervention are associated with changes in hepatic/peripheral insulin sensitivity or liver fat content
  • Investigate potential mechanism of the effects of dietary fatty acids; e.g. gene expression and lipogenic enzyme activity

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • abdominal obese subjects with or without type 2 diabetes
  • sagittal abdominal diameter >25cm

Exclusion criteria

  • insulin treatment
  • history of serious cardiovascular events
  • morbid obesity
  • claustrophobia (relative criterion)

Treatment and study plan

PUFA Diet

Other

Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).

SFA diet

Other

Diet high in saturated fat (15E%)

Primary outcomes

  1. Hepatic steatosis by MRT

    Time frame: 10 weeks

Secondary outcomes

  1. Insulin resistance by oral glucose tolerance test

    Time frame: 10 weeks

  2. Changes in adipose tissue gene expression and lipogenic enzyme activity

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Swedish Council for Working Life and Social Research

Registry information

Official study title

Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study

Acronym: HEPFAT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 23, 2009
Registry last updated
Jul 13, 2010

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.

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