Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance (HEPFAT)

July 12, 2010 updated by: Uppsala University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Specific goals:

  1. 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
  2. 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
  3. Investigate potential mechanism of the effects of dietary fatty acids; e.g. gene expression and lipogenic enzyme activity

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital, Uppsala Science Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PUFA diet
Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%)
Other: PUFA Diet
Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).
Active Comparator: SFA diet
Diet high in saturated fat (15 E%)
Other: SFA diet
Diet high in saturated fat (15E%)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hepatic steatosis by MRT
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Insulin resistance by oral glucose tolerance test
Time Frame: 10 weeks
10 weeks
Changes in adipose tissue gene expression and lipogenic enzyme activity
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Swedish Council for Working Life and Social Research

Investigators

  • Principal Investigator: Ulf Risérus, PhD, Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 21, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

July 13, 2010

Last Update Submitted That Met QC Criteria

July 12, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAS-2008-1364
  • CKFUU-45521 (Other Grant/Funding Number: Center for clinical research Dalarna 2009)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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