HyperlipidemiaPhase 2/3LPNINCT03141827
The Effect of Intranasal Insulin on Hepatic and Intestinal Triglyceride-rich Lipoprotein Production
A Phase 2/3 study testing Insulin in people with Hyperlipidemia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood by controlling the amount of fat made by the liver and gut. Recent research suggests that insulin may work through the brain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Insulin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2016to 26 Apr 2017
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, aged 18 to 60 years
- Body mass index 20 to 40 kg/m2
- Hemoglobin in the normal range.
- Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
- Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.
Who cannot join
- Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.
- Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
- Any current or previous history of endocrine disease, dyslipidemia or malignancy
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine > 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic pressure > 100 or systolic > 180 or systolic pressure <100) or proliferative retinopathy
- Use of immunosuppressive agents at any time during the study
- Allergy to any study medication
Show all 12Show fewer
- Pregnancy or breastfeeding
- Heavy smoker
- Fasting blood glucose > 6.0 mmol/l or known diabetes.
- Any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on electrocardiogram, unstable angina, or decompensated heart failure.
- Any nasal pathology.
- Any laboratory values: aspartate aminotransferase > 2x upper limit of normal ; alanine aminotransferase > 2x upper limit of normal; thyroid-stimulating hormone > 6 milliunit per litre
Trial locations and contacts
1 site in 1 country.
About this study
This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood by controlling the amount of fat made by the liver and gut. Recent research suggests that insulin may work through the brain. The investigators hypothesize that preferential delivery of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats made by the liver and gut.
Read the detailed description
Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. In study A they will receive a single dose of insulin 40 IU through nasal spray. In study B they will receive placebo. On the day of the study subjects will drink regular liquid nutrient formula to maintain a constant fed state. A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) will be started at 7am. From 9am a regular infusion of a stable isotope tracer will be started together with nasal spray of either insulin/placebo. Regular blood samples will be drawn to assess lipoprotein kinetics.
- Conditions
- Hyperlipidemia
- Being tested
- Insulin, Placebo
- Keywords
- Lipoprotein, Apolipoprotein, Pancreatic clamp, Insulin, Nasal
- Medical subject headings
- Hyperlipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Insulin 40 IU, nasal spray, single dose
PlaceboDrug
Placebo, nasal spray, single dose
| Study group | Role | What they receive |
|---|---|---|
| Insulin | Experimental | Nasal spray, insulin 40 IU, single dose Receives: Drug: Insulin |
| Placebo | Placebo comparator | Nasal spray, placebo, single dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglyceride-rich lipoprotein apolipoprotein B100 production rate
Triglyceride-rich lipoprotein apolipoprotein B100 production rate will be measured following nasal spray of insulin or placebo
Measured: 10 hours
Secondary outcomes (1)
Triglyceride-rich lipoprotein apolipoprotein B48 production rate
Triglyceride-rich lipoprotein apolipoprotein B48 production rate will be measured following nasal spray of insulin or placebo
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start14 Apr 2016
- Primary completion15 Feb 2017
- Study completion26 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary F Lewis, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03141827
- Sponsor's protocol ID
- LPNI-REB-15-9475
- Acronym
- LPNI
- Status last verified
- May 2017
- First submitted
- 3 May 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Xiao C, Dash S, Stahel P, Lewis GF. Effects of Intranasal Insulin on Triglyceride-Rich Lipoprotein Particle Production in Healthy Men. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1776-1781. doi: 10.1161/ATVBAHA.117.309705. Epub 2017 Jul 27.
PubMed 28751575
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Insulin on Hepatic and Intestinal Triglyceride-rich Lipoprotein Production
- ClinicalTrials.gov ID
- NCT03141827
- Acronym / sponsor ID
- LPNI / LPNI-REB-15-9475
- Conditions
- Hyperlipidemia
- Keywords
- Lipoprotein, Apolipoprotein, Pancreatic clamp, Insulin, Nasal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 15 Feb 2017 (actual)
- Study completion
- 26 Apr 2017 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
This study compares the effect of insulin given as a nasal spray with a placebo. Insulin is a chemical messenger (hormone) in the body that controls fat (triglyceride) levels in the blood by controlling the amount of fat made by the liver and gut. Recent research suggests that insulin may work through the brain. The investigators hypothesize that preferential delivery of insulin into the brain, through nasal spray of the hormone, may affect the amount of fats made by the liver and gut.
Detailed description
Each subject will be studied twice 4-6 weeks apart in random order in this single blinded study. In study A they will receive a single dose of insulin 40 IU through nasal spray. In study B they will receive placebo. On the day of the study subjects will drink regular liquid nutrient formula to maintain a constant fed state. A pancreatic clamp (octreotide with replacement glucose, insulin and growth hormone) will be started at 7am. From 9am a regular infusion of a stable isotope tracer will be started together with nasal spray of either insulin/placebo. Regular blood samples will be drawn to assess lipoprotein kinetics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin | Experimental | Drug: InsulinNasal spray, insulin 40 IU, single dose |
| Placebo | Placebo comparator | Drug: PlaceboNasal spray, placebo, single dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women, aged 18 to 60 years
- Body mass index 20 to 40 kg/m2
- Hemoglobin in the normal range.
- Normal glucose tolerance in response to a 75g, 2-hr oral glucose tolerance test
- Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study.
Key exclusion criteria (12 listed)
- Study participant with a history of hepatitis/hepatic disease that has been active within the previous two years.
- Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
- Any current or previous history of endocrine disease, dyslipidemia or malignancy
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (creatinine > 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic pressure > 100 or systolic > 180 or systolic pressure <100) or proliferative retinopathy
- Use of immunosuppressive agents at any time during the study
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 |
|---|---|---|
| InsulinInsulin 40 IU, nasal spray, single dose | Drug | Insulin |
| PlaceboPlacebo, nasal spray, single dose | Drug | Placebo |
Primary outcome
Triglyceride-rich lipoprotein apolipoprotein B100 production rate
Time frame: 10 hours
Triglyceride-rich lipoprotein apolipoprotein B100 production rate will be measured following nasal spray of insulin or placebo
1 secondary outcome
Triglyceride-rich lipoprotein apolipoprotein B48 production rate
Time frame: 10 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 8 May 2017.
- Derived from this study: PubMed 28751575Xiao C, Dash S, Stahel P, Lewis GF. Effects of Intranasal Insulin on Triglyceride-Rich Lipoprotein Particle Production in Healthy Men. Arterioscler Thromb Vasc Biol. 2017 Sep;37(9):1776-1781. doi: 10.1161/ATVBAHA.117.309705. Epub 2017 Jul 27.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insulin in people with Hyperlipidemia, 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 5 inclusion and 12 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 8 May 2017. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Triglyceride-rich lipoprotein apolipoprotein B100 production rate (time frame: 10 hours). 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 NCT03141827, which also lists 1 linked publication.
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 8 May 2017.