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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Canada1 site
  • University Health Network

    Toronto, Ontario, M5G 2c4

Other trials in Canada

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:

  1. 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,
  2. Saline infusion control study, and
  3. 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.

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.

  1. 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.

  1. First posted9 Sep 2005 (estimated)
  2. Study startApr 2005
  3. Primary completionJul 2008
  4. Study completionOct 2008

Resources

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)
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

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.

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