HealthyPhase 2NCT02607839
Regulation of Intestinal and Hepatic Lipoprotein Particle Production by Blood Glucose in Humans
A Phase 2 study testing glucose or normal saline in people with Healthy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The purpose of study is to examine whether raised blood glucose enhances lipid particle production independent of effects on gastric emptying and pancreatic/ gastrointestinal hormone production. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- glucose or normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Sep 2015
- Phase
- Phase 2
- 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 kg/m2 to 27 kg/m2
- Hemoglobin above 130g/L
- Normal glucose tolerance in response to a 75g, 2-hr OGTT
Who cannot join
- Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
- Any subject with active bleeding, bleeding diathesis, clotting abnormalities or recent surgery (within past 1 month)
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180).
- History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
- Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
- Any laboratory values: AST > 2x ULN; ALT > 2x ULN TSH > 6 mU/l
Show all 12Show fewer
- Current addiction to alcohol or substances of abuse as determined by the investigator.
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- Taking any prescription or non-prescription medications at the time of the study
- Having donated blood three months prior to and three months post study procedures
- A pregnancy test will be performed 1 to 3 days prior to each study in all female subjects. Those who test positive for pregnancy will be excluded.
- Known allergy, hypersensitivity or contraindication to receiving study medications.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of study is to examine whether raised blood glucose enhances lipid particle production independent of effects on gastric emptying and pancreatic/ gastrointestinal hormone production.
Read the detailed description
This study will be performed on healthy, lean, non-diabetic males and females who will participate two studies each in random order, 4 to 6 weeks apart. Study A: lipoprotein turnover with intravenous infusion of normal saline. Study B: lipoprotein turnover i.v infusion of glucose. In both studies, subjects will drink a liquid formula every hour to remain in a constant fed state and will be under conditions of pancreatic clamp (with the infusion of hormones somatostatin, insulin, glucagon, growth hormone). Subjects will be blinded with regard to the treatments.
- Conditions
- Healthy
- Being tested
- glucose or normal saline
- Keywords
- lipid handling by the gut and liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glucose or normal salineBiological
20% glucose solution or normal saline, intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| normal saline | Placebo comparator | normal saline intravenous infusion Receives: Biological: glucose or normal saline |
| glucose | Active comparator | glucose intravenous infusion Receives: Biological: glucose or normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Production of TRL-apoB48 between treatments
Measured: 10 hours
Secondary outcomes (1)
Production of TRL-apoB100 between treatments
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 posted18 Nov 2015 (estimated)
- Study startFeb 2013
- Primary completionApr 2015
- Study completionSep 2015
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 HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607839
- Sponsor's protocol ID
- 12-5569-B
- Status last verified
- Nov 2015
- First submitted
- 16 Nov 2015
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Xiao C, Dash S, Morgantini C, Lewis GF. Intravenous Glucose Acutely Stimulates Intestinal Lipoprotein Secretion in Healthy Humans. Arterioscler Thromb Vasc Biol. 2016 Jul;36(7):1457-63. doi: 10.1161/ATVBAHA.115.307044. Epub 2016 May 5.
PubMed 27150393
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Intestinal and Hepatic Lipoprotein Particle Production by Blood Glucose in Humans
- ClinicalTrials.gov ID
- NCT02607839
- Acronym / sponsor ID
- 12-5569-B
- Conditions
- Healthy
- Keywords
- lipid handling by the gut and liver
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Nov 2015 (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 study is to examine whether raised blood glucose enhances lipid particle production independent of effects on gastric emptying and pancreatic/ gastrointestinal hormone production.
Detailed description
This study will be performed on healthy, lean, non-diabetic males and females who will participate two studies each in random order, 4 to 6 weeks apart. Study A: lipoprotein turnover with intravenous infusion of normal saline. Study B: lipoprotein turnover i.v infusion of glucose. In both studies, subjects will drink a liquid formula every hour to remain in a constant fed state and will be under conditions of pancreatic clamp (with the infusion of hormones somatostatin, insulin, glucagon, growth hormone). Subjects will be blinded with regard to the treatments.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal saline | Placebo comparator | Biological: glucose or normal salinenormal saline intravenous infusion |
| glucose | Active comparator | Biological: glucose or normal salineglucose intravenous infusion |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Men and women, aged 18 to 60 years
- Body mass index 20 kg/m2 to 27 kg/m2
- Hemoglobin above 130g/L
- Normal glucose tolerance in response to a 75g, 2-hr OGTT
Key exclusion criteria (12 listed)
- Subject has a history of hepatitis/hepatic disease that has been active within the previous two years.
- Any subject with active bleeding, bleeding diathesis, clotting abnormalities or recent surgery (within past 1 month)
- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL), genitourinary, hematological systems, or has severe uncontrolled treated or untreated hypertension (sitting diastolic BP > 100 or systolic > 180).
- History of diabetes or OGTT indicative of diabetes or impaired glucose tolerance.
- Any history of a MI or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on ECG, unstable angina, or decompensated heart failure.
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 |
|---|---|---|
| glucose or normal saline20% glucose solution or normal saline, intravenous infusion | Biological | glucose, normal saline |
Primary outcome
Production of TRL-apoB48 between treatments
Time frame: 10 hours
1 secondary outcome
Production of TRL-apoB100 between treatments
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 18 Nov 2015.
- Derived from this study: PubMed 27150393Xiao C, Dash S, Morgantini C, Lewis GF. Intravenous Glucose Acutely Stimulates Intestinal Lipoprotein Secretion in Healthy Humans. Arterioscler Thromb Vasc Biol. 2016 Jul;36(7):1457-63. doi: 10.1161/ATVBAHA.115.307044. Epub 2016 May 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing glucose or normal saline in people with Healthy, 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 4 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 18 Nov 2015. 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 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.
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?
Production of TRL-apoB48 between treatments (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 NCT02607839, 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 18 Nov 2015.