Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance

NCT ID: NCT01038102

Last Updated: 2010-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-04-30

Brief Summary

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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

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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

Conditions

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Obesity Diabetes Insulin Resistance Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PUFA diet

Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%)

Group Type ACTIVE_COMPARATOR

PUFA Diet

Intervention Type OTHER

Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).

SFA diet

Diet high in saturated fat (15 E%)

Group Type ACTIVE_COMPARATOR

SFA diet

Intervention Type OTHER

Diet high in saturated fat (15E%)

Interventions

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PUFA Diet

Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).

Intervention Type OTHER

SFA diet

Diet high in saturated fat (15E%)

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swedish Council for Working Life and Social Research

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Uppsala University

Principal Investigators

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Ulf Risérus, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University

Locations

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Uppsala University Hospital, Uppsala Science Park

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 11914742 (View on PubMed)

Yki-Jarvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. doi: 10.1080/07853890510037383.

Reference Type BACKGROUND
PMID: 16179270 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22492369 (View on PubMed)

Other Identifiers

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CKFUU-45521

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

FAS-2008-1364

Identifier Type: -

Identifier Source: org_study_id

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