Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance

Obesity Clinical Trial

— HEPFAT  

Official title:

Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01038102
• Other study ID #: FAS-2008-1364
• Secondary ID: CKFUU-45521
• Status: Completed
• Phase: N/A
• First received: December 21, 2009
• Last updated: July 12, 2010
• Start date: February 2009
• Est. completion date: April 2010

Study information

• Verified date: December 2009
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board, Uppsala
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes
• Fatty Liver
• Insulin Resistance
• Obesity

Intervention

Other:
• PUFA Diet
Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).
• SFA diet
Diet high in saturated fat (15E%)

Locations

Country	Name	City	State
Sweden	Uppsala University Hospital, Uppsala Science Park	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Swedish Council for Working Life and Social Research

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic steatosis by MRT		10 weeks	No
Secondary	Insulin resistance by oral glucose tolerance test		10 weeks	No
Secondary	Changes in adipose tissue gene expression and lipogenic enzyme activity		10 weeks	No