ObesityHEPFATNCT01038102
Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance
A study testing PUFA Diet and SFA diet in people with Obesity and Diabetes, run by Uppsala University at 1 site in Sweden.
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 Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Diabetes, Insulin Resistance
- What is being tested?
- PUFA Diet and SFA diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- abdominal obese subjects with or without type 2 diabetes
- sagittal abdominal diameter >25cm
Who cannot join
- insulin treatment
- history of serious cardiovascular events
- morbid obesity
- claustrophobia (relative criterion)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study
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
Read the 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
- Conditions
- Obesity, Diabetes, Insulin Resistance, Fatty Liver
- Being tested
- PUFA Diet, SFA diet
- Keywords
- Obesity, Diabetes, Insulin resistance, Fatty liver, NAFLD, Steatosis, Dietary fatty acids
- Medical subject headings
- Obesity, Diabetes Mellitus, Insulin Resistance, Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUFA DietOther
Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%).
SFA dietOther
Diet high in saturated fat (15E%)
| Study group | Role | What they receive |
|---|---|---|
| PUFA diet | Active comparator | Diet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%) Receives: Other: PUFA Diet |
| SFA diet | Active comparator | Diet high in saturated fat (15 E%) Receives: Other: SFA diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic steatosis by MRT
Measured: 10 weeks
Secondary outcomes (2)
Insulin resistance by oral glucose tolerance test
Measured: 10 weeks
Changes in adipose tissue gene expression and lipogenic enzyme activity
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Investigators
- Ulf Risérus, PhD, Principal investigator, Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038102
- Sponsor's protocol ID
- FAS-2008-1364
- Other IDs
- CKFUU-45521
- Acronym
- HEPFAT
- Status last verified
- Dec 2009
- First submitted
- 21 Dec 2009
- Last updated
- 13 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1007/s00125-001-0768-3.
PubMed 11914742Yki-Jarvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. doi: 10.1080/07853890510037383.
PubMed 16179270Bjermo 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.
PubMed 22492369
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dietary Fatty Acids in Fatty Liver and Insulin Resistance: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01038102
- Acronym / sponsor ID
- HEPFAT / FAS-2008-1364
- Conditions
- Obesity, Diabetes, Insulin Resistance, Fatty Liver
- Keywords
- Obesity, Diabetes, Insulin resistance, Fatty liver, NAFLD, Steatosis, Dietary fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Swedish Council for Working Life and Social Research
- Study start
- Feb 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUFA diet | Active comparator | Other: PUFA DietDiet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%) |
| SFA diet | Active comparator | Other: SFA dietDiet high in saturated fat (15 E%) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- abdominal obese subjects with or without type 2 diabetes
- sagittal abdominal diameter >25cm
Key exclusion criteria (4 listed)
- insulin treatment
- history of serious cardiovascular events
- morbid obesity
- claustrophobia (relative criterion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUFA DietDiet high in polyunsaturated (rich in linoleic acid, omega-6) fat (15 E%). | Other | PUFA diet |
| SFA dietDiet high in saturated fat (15E%) | Other | SFA diet |
Primary outcome
Hepatic steatosis by MRT
Time frame: 10 weeks
2 secondary outcomes
Insulin resistance by oral glucose tolerance test
Time frame: 10 weeks
Changes in adipose tissue gene expression and lipogenic enzyme activity
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2010.
- Background: PubMed 11914742Summers 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.
- Background: PubMed 16179270Yki-Jarvinen H. Fat in the liver and insulin resistance. Ann Med. 2005;37(5):347-56. doi: 10.1080/07853890510037383.
- Derived from this study: PubMed 22492369Bjermo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Risérus, PhD principal investigator
Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PUFA Diet and SFA diet in people with Obesity and Diabetes, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic steatosis by MRT (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038102, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2010.