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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

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

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

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

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

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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