Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance (HEPFAT)
Primary Purpose
Obesity, Diabetes, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PUFA Diet
SFA diet
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Diabetes, Insulin resistance, Fatty liver, NAFLD, Steatosis, Dietary fatty acids
Eligibility 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)
Sites / Locations
- Uppsala University Hospital, Uppsala Science Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PUFA diet
SFA diet
Arm Description
Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%)
Diet high in saturated fat (15 E%)
Outcomes
Primary Outcome Measures
Hepatic steatosis by MRT
Secondary Outcome Measures
Insulin resistance by oral glucose tolerance test
Changes in adipose tissue gene expression and lipogenic enzyme activity
Full Information
NCT ID
NCT01038102
First Posted
December 21, 2009
Last Updated
July 12, 2010
Sponsor
Uppsala University
Collaborators
Swedish Council for Working Life and Social Research
1. Study Identification
Unique Protocol Identification Number
NCT01038102
Brief Title
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance
Acronym
HEPFAT
Official Title
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Uppsala University
Collaborators
Swedish Council for Working Life and Social Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Diabetes, Insulin Resistance, Fatty Liver
Keywords
Obesity, Diabetes, Insulin resistance, Fatty liver, NAFLD, Steatosis, Dietary fatty acids
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PUFA diet
Arm Type
Active Comparator
Arm Description
Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%)
Arm Title
SFA diet
Arm Type
Active Comparator
Arm Description
Diet high in saturated fat (15 E%)
Intervention Type
Other
Intervention Name(s)
PUFA Diet
Intervention Description
Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).
Intervention Type
Other
Intervention Name(s)
SFA diet
Intervention Description
Diet high in saturated fat (15E%)
Primary Outcome Measure Information:
Title
Hepatic steatosis by MRT
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Insulin resistance by oral glucose tolerance test
Time Frame
10 weeks
Title
Changes in adipose tissue gene expression and lipogenic enzyme activity
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Risérus, PhD
Organizational Affiliation
Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital, Uppsala Science Park
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
11914742
Citation
Summers LK, Fielding BA, Bradshaw HA, Ilic V, Beysen C, Clark ML, Moore NR, Frayn KN. Substituting dietary saturated fat with polyunsaturated fat changes abdominal fat distribution and improves insulin sensitivity. Diabetologia. 2002 Mar;45(3):369-77. doi: 10.1007/s00125-001-0768-3.
Results Reference
background
PubMed Identifier
16179270
Citation
Yki-Jarvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. doi: 10.1080/07853890510037383.
Results Reference
background
PubMed Identifier
22492369
Citation
Bjermo H, Iggman D, Kullberg J, Dahlman I, Johansson L, Persson L, Berglund J, Pulkki K, Basu S, Uusitupa M, Rudling M, Arner P, Cederholm T, Ahlstrom H, Riserus U. Effects of n-6 PUFAs compared with SFAs on liver fat, lipoproteins, and inflammation in abdominal obesity: a randomized controlled trial. Am J Clin Nutr. 2012 May;95(5):1003-12. doi: 10.3945/ajcn.111.030114. Epub 2012 Apr 4.
Results Reference
derived
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Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance
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