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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038102
First Posted: December 23, 2009
Last Update Posted: July 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by:
Uppsala University
  Purpose
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

Condition Intervention
Obesity Diabetes Insulin Resistance Fatty Liver Other: PUFA Diet Other: SFA diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Hepatic steatosis by MRT [ Time Frame: 10 weeks ]

Secondary Outcome Measures:
  • Insulin resistance by oral glucose tolerance test [ Time Frame: 10 weeks ]
  • Changes in adipose tissue gene expression and lipogenic enzyme activity [ Time Frame: 10 weeks ]

Enrollment: 65
Study Start Date: February 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%)

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01038102


Locations
Sweden
Uppsala University Hospital, Uppsala Science Park
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
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
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ulf Risérus, Ass. professor, Uppsala University
ClinicalTrials.gov Identifier: NCT01038102     History of Changes
Other Study ID Numbers: FAS-2008-1364
CKFUU-45521 ( Other Grant/Funding Number: Center for clinical research Dalarna 2009 )
First Submitted: December 21, 2009
First Posted: December 23, 2009
Last Update Posted: July 13, 2010
Last Verified: December 2009

Keywords provided by Uppsala University:
Obesity
Diabetes
Insulin resistance
Fatty liver
NAFLD
Steatosis
Dietary fatty acids

Additional relevant MeSH terms:
Insulin Resistance
Fatty Liver
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs