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

History of Changes

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:

MedlinePlus related topics: Diabetes Diabetes Medicines Obesity

Drug Information available for: Insulin human

U.S. FDA Resources

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:

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

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

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:

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.

Yki-Järvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Ahlström H, Risérus 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. Epub 2012 Apr 4.

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 June 17, 2013

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