Insulin ResistanceNCT01541592
Does Class of Dietary Fat Affect Insulin Resistance?
A study testing Dietary fat in people with Insulin Resistance, run by Mayo Clinic at 1 site in United States.
Trial summary
It has been shown that intravenous fatty acids given to normal volunteers in the form of heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is not known if this same phenomenon can be demonstrated with oral fat. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Dietary fat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Feb 2014
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lean,healthy adults 18 - 40
- No chronic medications (birth control pills allowed)
- Weight stable
- Normal fasting labs performed at screening
- Body mass index ≤ 25 kg/M^2 .
Who cannot join
- Insulin dependent diabetes
- Thyroid disease
- History of diabetes or heart disease
- History of type 2 diabetes in parent or sibling
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Insulin Resistance and Dietary Fat
It has been shown that intravenous fatty acids given to normal volunteers in the form of heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is not known if this same phenomenon can be demonstrated with oral fat. The investigators are specifically interested in whether or not there are differences in the induction of insulin resistance between the 3 main classes of fatty acids (saturated, monounsaturated and polyunsaturated).
The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of which frequently accompany insulin resistance.
Read the detailed description
Type 2 Diabetes and cardiovascular disease are closely linked. A common abnormality in both conditions is insulin resistance. The primary cause of insulin resistance in not known. A significant question is what dietary components contribute to the development of insulin resistance. Based on epidemiologic data, it seems that the type of dietary fat is a significant contributor to the development of insulin resistance. However, some researchers argue that the main determinant is total amount of fat, not the composition.
This study is intended to determine if the main types of fat (saturated, monounsaturated and polyunsaturated) ingested over a short time can cause insulin resistance in lean, healthy people. It has been demonstrated that 6 hours of intravenous fat infused into lean, healthy subjects can result in insulin resistance, as well as blood pressure elevation and endothelial dysfunction. Whether this is so with oral fat is not known. The question is important because there is debate about whether the type of fat is as important as the quantity of fat in a person's daily diet. Settling this debate will enhance the ability of health care personnel to determine the optimal dietary recommendations.
This study will make use of a high fat diet consisting of vegetable oils high in the 3 main fatty acids in plasma (palmitate, oleate and linoleate). Because large fat loads can cause intestinal discomfort, a feeding tube will be used to bypass the stomach. The 3 oils will be assigned randomly following a base line study with saline 2 weeks prior to the intervention. Our primary endpoint is insulin resistance, which will be measured by a euglycemic, hyperinsulinemic clamp. Secondary measures will include changes in blood pressure and in vascular reactivity as measured by ultrasound after brief occlusion of a forearm vessel. The changes will be compared to baseline and to the other 2 groups.
- Conditions
- Insulin Resistance
- Being tested
- Dietary fat
- Keywords
- Insulin resistance, Endothelial dysfunction, saturated fat, monounsaturated fat, polyunsaturated fat
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary fatOther
On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of ~1 tablespoon per hour so that the total infusion time will be 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Saturated fat | Active comparator | Palm oil (rich in the saturated fat palmitate) Receives: Other: Dietary fat |
| Monounsaturated fat | Active comparator | Olive oil (rich in the monounsaturated fat oleate) Receives: Other: Dietary fat |
| Polyunsaturated fat | Active comparator | Safflower oil (rich in the polyunsaturated fat linoleate) Receives: Other: Dietary fat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insulin Sensitivity from Baseline at Two Weeks
Insulin sensitivity will be measured twice (once at baseline following a nasoduodenal infusion of saline for 6 hours; two weeks later following a nasoduodenal infusion of a vegetable oil high in one of 3 fatty acids for 6 hours) using a euglycemic, hyperinsulinemic clamp as described by R. DeFronzo. The actual measurement is expressed as a glucose infusion rate.
Measured: Average of 2 weeks.
Secondary outcomes (2)
Change in Endothelial Function from Baseline at Two Weeks
Endothelial function will be measured by measuring the dilation of the brachial artery in the elbow following occlusion by a blood pressure cuff, which is then released. The actual measurement involves use of ultrasound by an investigator experienced with this technique.
Measured: Average of two weeks
Change in Systolic Blood Pressure at Two Weeks
Blood pressure will be measured using a standard automated blood pressure cuff. The measurements will be taken several times during each study day.
Measured: Average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert.H.Nelson, Mayo Clinic
- Investigators
- Robert Nelson, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541592
- Sponsor's protocol ID
- 11-000179
- Status last verified
- Nov 2014
- First submitted
- 21 Feb 2012
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Dietary Fat
- ClinicalTrials.gov ID
- NCT01541592
- Acronym / sponsor ID
- 11-000179
- Conditions
- Insulin Resistance
- Keywords
- Insulin resistance, Endothelial dysfunction, saturated fat, monounsaturated fat, polyunsaturated fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 1 Mar 2012 (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.
It has been shown that intravenous fatty acids given to normal volunteers in the form of heparin and lipid emulsions will cause insulin resistance in a matter of a few hours. It is not known if this same phenomenon can be demonstrated with oral fat. The investigators are specifically interested in whether or not there are differences in the induction of insulin resistance between the 3 main classes of fatty acids (saturated, monounsaturated and polyunsaturated).
The investigators also plan to evaluate endothelial dysfunction and blood pressure; both of which frequently accompany insulin resistance.
Detailed description
Type 2 Diabetes and cardiovascular disease are closely linked. A common abnormality in both conditions is insulin resistance. The primary cause of insulin resistance in not known. A significant question is what dietary components contribute to the development of insulin resistance. Based on epidemiologic data, it seems that the type of dietary fat is a significant contributor to the development of insulin resistance. However, some researchers argue that the main determinant is total amount of fat, not the composition.
This study is intended to determine if the main types of fat (saturated, monounsaturated and polyunsaturated) ingested over a short time can cause insulin resistance in lean, healthy people. It has been demonstrated that 6 hours of intravenous fat infused into lean, healthy subjects can result in insulin resistance, as well as blood pressure elevation and endothelial dysfunction. Whether this is so with oral fat is not known. The question is important because there is debate about whether the type of fat is as important as the quantity of fat in a person's daily diet. Settling this debate will enhance the ability of health care personnel to determine the optimal dietary recommendations.
This study will make use of a high fat diet consisting of vegetable oils high in the 3 main fatty acids in plasma (palmitate, oleate and linoleate). Because large fat loads can cause intestinal discomfort, a feeding tube will be used to bypass the stomach. The 3 oils will be assigned randomly following a base line study with saline 2 weeks prior to the intervention. Our primary endpoint is insulin resistance, which will be measured by a euglycemic, hyperinsulinemic clamp. Secondary measures will include changes in blood pressure and in vascular reactivity as measured by ultrasound after brief occlusion of a forearm vessel. The changes will be compared to baseline and to the other 2 groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saturated fat | Active comparator | Other: Dietary fatPalm oil (rich in the saturated fat palmitate) |
| Monounsaturated fat | Active comparator | Other: Dietary fatOlive oil (rich in the monounsaturated fat oleate) |
| Polyunsaturated fat | Active comparator | Other: Dietary fatSafflower oil (rich in the polyunsaturated fat linoleate) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Lean,healthy adults 18 - 40
- No chronic medications (birth control pills allowed)
- Weight stable
- Normal fasting labs performed at screening
- Body mass index ≤ 25 kg/M^2 .
Key exclusion criteria (4 listed)
- Insulin dependent diabetes
- Thyroid disease
- History of diabetes or heart disease
- History of type 2 diabetes in parent or sibling
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 |
|---|---|---|
| Dietary fatOn the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of ~1 tablespoon per hour so that the total infusion time will be 6 hours. | Other | Monounsaturated fat, Polyunsaturated fat, Saturated fat |
Primary outcome
Change in Insulin Sensitivity from Baseline at Two Weeks
Time frame: Average of 2 weeks.
Insulin sensitivity will be measured twice (once at baseline following a nasoduodenal infusion of saline for 6 hours; two weeks later following a nasoduodenal infusion of a vegetable oil high in one of 3 fatty acids for 6 hours) using a euglycemic, hyperinsulinemic clamp as described by R. DeFronzo. The actual measurement is expressed as a glucose infusion rate.
2 secondary outcomes
Change in Endothelial Function from Baseline at Two Weeks
Time frame: Average of two weeks
Change in Systolic Blood Pressure at Two Weeks
Time frame: Average of two 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 26 Nov 2014.
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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.
Robert Nelson, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary fat in people with Insulin Resistance, run by Mayo Clinic at 1 site in United States.
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 5 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 26 Nov 2014. 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 United States. 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?
Change in Insulin Sensitivity from Baseline at Two Weeks (time frame: Average of 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2014.