Clinical trial NCT01038102: Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance
Official title: Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Insulin Resistance
Fatty Liver
Keywords: Obesity
Diabetes
Insulin resistance
Fatty liver
NAFLD
Steatosis
Dietary fatty acids
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Swedish Council for Working Life and Social Research
First posted: 2009-12-23
Enrollment: 65
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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

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)

Primary outcomes:
measure: Hepatic steatosis by MRT
timeFrame: 10 weeks
Secondary outcomes:
measure: Insulin resistance by oral glucose tolerance test
timeFrame: 10 weeks
measure: Changes in adipose tissue gene expression and lipogenic enzyme activity
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Uppsala Science Park
Study officials:
affiliation: Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
name: Ulf Risérus, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Yki-Jarvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. doi: 10.1080/07853890510037383.
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.