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

This study has been completed.
Sponsor:
Collaborator:
Swedish Council for Working Life and Social Research
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT01038102
First received: December 21, 2009
Last updated: July 12, 2010
Last verified: December 2009
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin resistance by oral glucose tolerance test [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Changes in adipose tissue gene expression and lipogenic enzyme activity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: December 21, 2009
Last Updated: July 12, 2010
Health Authority: Sweden: Regional Ethical Review Board, Uppsala

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

Additional relevant MeSH terms:
Diabetes Mellitus
Fatty Liver
Insulin Resistance
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014