Insulin ResistanceNCT00152945
Determining the Responsiveness of Intestinal Lipoprotein Production to an Elevation of Plasma Free Fatty Acids
A study testing Intravenous Intralipid and Intravenous leucine, glycerol in people with Insulin Resistance, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Lipoproteins are large complexes of molecules that transport lipids (primarily triglycerides and cholesterol) through the blood. The intestine has traditionally been viewed as a 'passive' organ with respect to lipoprotein production, with intestinal lipoprotein production rates responding mainly to fat ingestion and… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Intravenous Intralipid and Intravenous leucine, glycerol
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Oct 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-diabetic men and women aged 18-65 years old
- Written informed consent obtained
- Body mass index (BMI) < 27 kg/m2
- Fasting triglycerides < 2.5 mmol/l
- Waist circumference < 90 cm
- Fasting blood glucose < 6 mmol/l
- Haemoglobin above 130 g/L.
Who cannot join
- Patient has a history of hepatitis/hepatic disease that has been active within the previous 2 years.
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine [Cr] > 1.5 mg/dL) genitourinary, or hematological systems; or severe uncontrolled treated or untreated hypertension (sitting diastolic blood pressure [BP] > 100 or systolic > 180); or proliferative retinopathy.
- Fasting blood glucose > 6 mmol/l or known diabetes.
- Any history of a myocardial infarction (MI) or clinically significant, active, cardiovascular history including a history of arrhythmias or conduction delays on electrocardiogram (ECG), unstable angina, or decompensated heart failure.
- Any laboratory values: AST > 2x upper limit of normal (ULN); ALT > 2x ULN; thyroid-stimulating hormone (TSH) > 6 mU/l.
- Known or suspected allergy to the medication or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions.
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- Current addiction to alcohol or substances of abuse as determined by the investigator.
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- Any lipid lowering or hypoglycemic agents
- Will not donate blood three months before start or three months after completing study.
- Thrombocytopenia
Trial locations and contacts
1 site in 1 country.
About this study
Lipoproteins are large complexes of molecules that transport lipids (primarily triglycerides and cholesterol) through the blood. The intestine has traditionally been viewed as a 'passive' organ with respect to lipoprotein production, with intestinal lipoprotein production rates responding mainly to fat ingestion and absorption. The investigators have recently demonstrated in animal models that there is an overproduction of intestinal lipoproteins in both the fasted and the fed state. The investigators have also recently demonstrated that an elevation of plasma free fatty acids (FFAs) stimulates intestinal lipoprotein in hamsters. It is not known whether intestinal lipoprotein production can be acutely stimulated by an elevation of plasma FFAs in humans.
Hypothesis: Intestinal lipoprotein particle production in humans can be stimulated by an acute elevation of plasma free fatty acids.
Read the detailed description
This study proposes to use a published stable isotope method to study the kinetics of apoB48 and apoB100 in the constant fed state in healthy subjects. These studies will be performed in 10 healthy, lean men and women aged 18 to 65 years of age. Each subject will serve as his/her own control and will undergo 3 separate lipoprotein turnover studies, in random order, 4 to 6 weeks apart. Since the infusion of intralipid (a synthetic triglyceride emulsion that provides a source of fatty acids) and heparin (to activate lipoprotein lipase) raises both FFAs and glycerol, two control studies will be performed, one with saline and one with glycerol infusion. ApoB48-containing lipoprotein particle production will be determined as outlined above but for this study in the fasted state, in response to the following interventions:
- Intralipid (20% solution @ 40 ml/hr) and heparin (250 u/hr) infusion to achieve an ~2-fold elevation of plasma FFAs (as previously shown), starting 90 minutes prior to and continuing throughout the lipoprotein turnover experiment,
- Saline infusion control study, and
- Glycerol control study in which glycerol will be infused at a rate of 2.25 g/hr to simulate the infusion of glycerol contained in Intralipid.
Stable isotope infusion protocol. Following a 14-h overnight fast, an IV will be inserted into a superficial vein in each forearm, one for infusion and one for sampling. At 7 am, a fasting blood sample will be drawn and the subject will begin to ingest the first of 15 identical small hourly meals, each equivalent to 1/15th of their daily food intake. This will be achieved by giving the patient the drink BOOST (Mead Johnson Nutritionals, Ottawa, On) and, using the Harris Benedict Equation (HBE) to determine the number of total energy requirements. This is based on height, weight, age and activity factors. The subject will have nothing else to eat until the end of the study. At the same time an IV infusion with either heparin plus intralipid or saline or glycerol as indicated above will be started. At 10 am (3 hours after starting the ingestion of hourly feeds), a primed-constant infusion of deuterium-labeled leucine ([D3]L-leucine 98%, Cambridge Isotope Laboratories, MA) will be started, as previously described (0.6 mg/kg as an initial injection and then 0.6 mg/kg/hr thereafter). In addition, an IV bolus of d5-glycerol (100 mmol/kg) will be administered. These are standard techniques used for the assessment of lipoprotein metabolism in humans. Leucine, an amino acid and glycerol, an intermediary metabolite, are used by cells in the body as building blocks for proteins, fats and for energy. The form of leucine that will be administered is deuterated leucine (chemical formula L-[5,5,5-2H3]) and the form of glycerol is d5-glycerol, which has been enriched with the naturally occurring isotope (chemical variant) of hydrogen (2H). Deuterated leucine and glycerol are stable isotopes that occur naturally in the environment and in the body, and there are no health/safety issues regarding the infusion of the amounts of deuterated leucine and glycerol indicated above. The solutions are prepared using sterile techniques and are monitored for contamination prior to administration. Blood samples will be collected prior to and at the following time points after administration of the stable isotopes: 1hr, 2hr, 3hr, 5hr, 7hr, 9hr, 10hr, 11hr and 12hr. A total of 340 ml of blood will be drawn.
- Conditions
- Insulin Resistance
- Being tested
- Intravenous Intralipid, Intravenous leucine, glycerol
- Keywords
- intestinal lipoprotein, very low density lipoprotein, free fatty acids, Apo B48 and Apo B100, triglycerides, Intestinal lipoprotein production
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous IntralipidDrug
intravenous infusion
Intravenous leucine, glycerolDrug
intravenous infusion
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the elevation of plasma FFAs by infusing intralipid and heparin stimulates intestinal lipoprotein production
Measured: blood samples at 1,2,3,5,7,9,10,11 and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionJul 2008
- Study completionOct 2008
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 University Health Network, TorontoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Lewis, University Health Network, Toronto
- Investigators
- Gary F Lewis, MD, Principal investigator, University Health Network, Toronto, Ontario, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152945
- Sponsor's protocol ID
- 04-0575-B
- Other IDs
- CIHR Grant 777509574
- Status last verified
- Sep 2012
- First submitted
- 8 Sep 2005
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Responsiveness of Intestinal Lipoprotein Production to an Elevation of Plasma Free Fatty Acids
- ClinicalTrials.gov ID
- NCT00152945
- Acronym / sponsor ID
- 04-0575-B
- Conditions
- Insulin Resistance
- Keywords
- intestinal lipoprotein, very low density lipoprotein, free fatty acids, Apo B48 and Apo B100, triglycerides, Intestinal lipoprotein production
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Sep 2005 (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.
Lipoproteins are large complexes of molecules that transport lipids (primarily triglycerides and cholesterol) through the blood. The intestine has traditionally been viewed as a 'passive' organ with respect to lipoprotein production, with intestinal lipoprotein production rates responding mainly to fat ingestion and absorption. The investigators have recently demonstrated in animal models that there is an overproduction of intestinal lipoproteins in both the fasted and the fed state. The investigators have also recently demonstrated that an elevation of plasma free fatty acids (FFAs) stimulates intestinal lipoprotein in hamsters. It is not known whether intestinal lipoprotein production can be acutely stimulated by an elevation of plasma FFAs in humans.
Hypothesis: Intestinal lipoprotein particle production in humans can be stimulated by an acute elevation of plasma free fatty acids.
Detailed description
This study proposes to use a published stable isotope method to study the kinetics of apoB48 and apoB100 in the constant fed state in healthy subjects. These studies will be performed in 10 healthy, lean men and women aged 18 to 65 years of age. Each subject will serve as his/her own control and will undergo 3 separate lipoprotein turnover studies, in random order, 4 to 6 weeks apart. Since the infusion of intralipid (a synthetic triglyceride emulsion that provides a source of fatty acids) and heparin (to activate lipoprotein lipase) raises both FFAs and glycerol, two control studies will be performed, one with saline and one with glycerol infusion. ApoB48-containing lipoprotein particle production will be determined as outlined above but for this study in the fasted state, in response to the following interventions:
- Intralipid (20% solution @ 40 ml/hr) and heparin (250 u/hr) infusion to achieve an ~2-fold elevation of plasma FFAs (as previously shown), starting 90 minutes prior to and continuing throughout the lipoprotein turnover experiment,
- Saline infusion control study, and
- Glycerol control study in which glycerol will be infused at a rate of 2.25 g/hr to simulate the infusion of glycerol contained in Intralipid.
Stable isotope infusion protocol. Following a 14-h overnight fast, an IV will be inserted into a superficial vein in each forearm, one for infusion and one for sampling. At 7 am, a fasting blood sample will be drawn and the subject will begin to ingest the first of 15 identical small hourly meals, each equivalent to 1/15th of their daily food intake. This will be achieved by giving the patient the drink BOOST (Mead Johnson Nutritionals, Ottawa, On) and, using the Harris Benedict Equation (HBE) to determine the number of total energy requirements. This is based on height, weight, age and activity factors. The subject will have nothing else to eat until the end of the study. At the same time an IV infusion with either heparin plus intralipid or saline or glycerol as indicated above will be started. At 10 am (3 hours after starting the ingestion of hourly feeds), a primed-constant infusion of deuterium-labeled leucine ([D3]L-leucine 98%, Cambridge Isotope Laboratories, MA) will be started, as previously described (0.6 mg/kg as an initial injection and then 0.6 mg/kg/hr thereafter). In addition, an IV bolus of d5-glycerol (100 mmol/kg) will be administered. These are standard techniques used for the assessment of lipoprotein metabolism in humans. Leucine, an amino acid and glycerol, an intermediary metabolite, are used by cells in the body as building blocks for proteins, fats and for energy. The form of leucine that will be administered is deuterated leucine (chemical formula L-[5,5,5-2H3]) and the form of glycerol is d5-glycerol, which has been enriched with the naturally occurring isotope (chemical variant) of hydrogen (2H). Deuterated leucine and glycerol are stable isotopes that occur naturally in the environment and in the body, and there are no health/safety issues regarding the infusion of the amounts of deuterated leucine and glycerol indicated above. The solutions are prepared using sterile techniques and are monitored for contamination prior to administration. Blood samples will be collected prior to and at the following time points after administration of the stable isotopes: 1hr, 2hr, 3hr, 5hr, 7hr, 9hr, 10hr, 11hr and 12hr. A total of 340 ml of blood will be drawn.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Non-diabetic men and women aged 18-65 years old
- Written informed consent obtained
- Body mass index (BMI) < 27 kg/m2
- Fasting triglycerides < 2.5 mmol/l
- Waist circumference < 90 cm
Key exclusion criteria (11 listed)
- Patient has a history of hepatitis/hepatic disease that has been active within the previous 2 years.
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine [Cr] > 1.5 mg/dL) genitourinary, or hematological systems; or severe uncontrolled treated or untreated hypertension (sitting diastolic blood pressure [BP] > 100 or systolic > 180); or proliferative retinopathy.
- Fasting blood glucose > 6 mmol/l or known diabetes.
- Any history of a myocardial infarction (MI) or clinically significant, active, cardiovascular history including a history of arrhythmias or conduction delays on electrocardiogram (ECG), unstable angina, or decompensated heart failure.
- Any laboratory values: AST > 2x upper limit of normal (ULN); ALT > 2x ULN; thyroid-stimulating hormone (TSH) > 6 mU/l.
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 |
|---|---|---|
| Intravenous Intralipidintravenous infusion | Drug | – |
| Intravenous leucine, glycerolintravenous infusion | Drug | – |
Primary outcome
To determine if the elevation of plasma FFAs by infusing intralipid and heparin stimulates intestinal lipoprotein production
Time frame: blood samples at 1,2,3,5,7,9,10,11 and 12 hours
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 2 Oct 2012.
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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.
Gary F Lewis, MD principal investigator
University Health Network, Toronto, Ontario, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Intralipid and Intravenous leucine, glycerol in people with Insulin Resistance, run by University Health Network, Toronto at 1 site in Canada.
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 7 inclusion and 11 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 2 Oct 2012. 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 Canada. 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?
To determine if the elevation of plasma FFAs by infusing intralipid and heparin stimulates intestinal lipoprotein production (time frame: blood samples at 1,2,3,5,7,9,10,11 and 12 hours). 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 2 Oct 2012.