Type 2 DiabetesPIPCNCT06462170
Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study
A study testing Boost Original meal replacement shake in people with Type 2 Diabetes, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months. In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Boost Original meal replacement shake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jun 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent provided
- Age >= 18 years.
- Diagnosed as type 2 diabetes mellitus.
- Not on insulin therapy.
Who cannot join
- Diagnosed as another form of diabetes mellitus.
- Allergic to one or more ingredients in Boost meal replacement shake.
- Unable to fast since midnight and attend in person for the morning protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H7W9
Cathy J Sun, MD MSc
About this study
Official title: The Feasibility of an Innovative Protocol to Demonstrate the Impact of Positive Energy Balance on Pancreatic Insulin Production Capacity (PIPC)
The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months.
In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours.
With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.
Read the detailed description
This study will measure the ability of the pancreas to produce insulin after the participant drinks a Boost Original meal replacement shake. The Boost Original meal replacement shake contains nutrients similar to a typical meal, and allows to standardize this "meal" for all participants. This is a cross-sectional study for 90 participants with type 2 diabetes mellitus who undergo a single study visit that lasts 2 hours with blood drawn at five time points. The area under the curve will be a quantitative measure of each participant's pancreatic insulin production capacity.
- Conditions
- Type 2 Diabetes
- Being tested
- Boost Original meal replacement shake
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boost Original meal replacement shakeDietary supplement
One bottle of Boost Original meal replacement shake.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic insulin production after drinking meal replacement shake | Experimental | Nutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity. Receives: Dietary Supplement: Boost Original meal replacement shake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake.
Participants will get blood drawn at time 0, 30, 60, 90, and 120 minutes. Blood will be sent for glucose, insulin, and C-peptide measurements. The area under the curve (AUC) will be calculated from these measurements. The AUC for insulin and for C-peptide will be representative of the participant's PIPC.
Measured: 12 months
Secondary outcomes (1)
The impact of participant's self-reported weight gain in the past year (12 months prior to the single study visit) on participant's PIPC.
Linear regression modelling will be used where weight gain is an independent variable, and PIPC is the dependent variable. The p-value for participant's self-reported weight gain will show the significance of impact on PIPC.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start24 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cathy Sun, MD MSc, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462170
- Sponsor's protocol ID
- 20240236-01H
- Acronym
- PIPC
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2024
- Last updated
- 6 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of an Innovative Protocol to Demonstrate the Impact of Positive Energy Balance on Pancreatic Insulin Production Capacity (PIPC)
- ClinicalTrials.gov ID
- NCT06462170
- Acronym / sponsor ID
- PIPC / 20240236-01H
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Jun 2024 (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.
The standard treatment for Type 2 diabetes involves management of the disease based on average of blood glucose control over the past few months.
In this study, the investigators test for the participants' ability to produce insulin, which is the hormone that the body makes to control blood sugar levels. The body produces insulin in response to eating. The participants will drink a meal replacement shake, and then test the blood for levels of insulin produced over 2 hours.
With blood tests taken five times over two hours, the investigators will measure the blood glucose (sugar), and insulin levels. This study will assess the differences in insulin produced in the participants and try to understand the reasons for these differences.
Detailed description
This study will measure the ability of the pancreas to produce insulin after the participant drinks a Boost Original meal replacement shake. The Boost Original meal replacement shake contains nutrients similar to a typical meal, and allows to standardize this "meal" for all participants. This is a cross-sectional study for 90 participants with type 2 diabetes mellitus who undergo a single study visit that lasts 2 hours with blood drawn at five time points. The area under the curve will be a quantitative measure of each participant's pancreatic insulin production capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic insulin production after drinking meal replacement shake | Experimental | Dietary Supplement: Boost Original meal replacement shakeNutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Consent provided
- Age >= 18 years.
- Diagnosed as type 2 diabetes mellitus.
- Not on insulin therapy.
Key exclusion criteria (3 listed)
- Diagnosed as another form of diabetes mellitus.
- Allergic to one or more ingredients in Boost meal replacement shake.
- Unable to fast since midnight and attend in person for the morning protocol.
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 |
|---|---|---|
| Boost Original meal replacement shakeOne bottle of Boost Original meal replacement shake. | Dietary supplement | Pancreatic insulin production after drinking meal replacement shake |
Primary outcome
Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake.
Time frame: 12 months
Participants will get blood drawn at time 0, 30, 60, 90, and 120 minutes. Blood will be sent for glucose, insulin, and C-peptide measurements. The area under the curve (AUC) will be calculated from these measurements. The AUC for insulin and for C-peptide will be representative of the participant's PIPC.
1 secondary outcome
The impact of participant's self-reported weight gain in the past year (12 months prior to the single study visit) on participant's PIPC.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- 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.
Cathy Sun, MD MSc principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boost Original meal replacement shake in people with Type 2 Diabetes, run by Ottawa Hospital Research Institute 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 3 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathy Sun, MD MSc (613-738-8333, csun@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake. (time frame: 12 months). 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 6 May 2026.