Testing insulin production in people with type 2 diabetes
The Feasibility of an Innovative Protocol to Demonstrate the Impact of Positive Energy Balance on Pancreatic Insulin Production Capacity (PIPC)
This study tests how well the pancreas makes insulin in people with type 2 diabetes after they drink a meal replacement shake.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06462170 on ClinicalTrials.gov |
What this trial studies
This study evaluates the ability of the pancreas to produce insulin in individuals with type 2 diabetes. Participants will consume a standardized meal replacement shake, and their blood will be tested for insulin and glucose levels over a two-hour period. The study aims to measure differences in insulin production among participants and understand the underlying reasons for these differences. A total of 90 participants will be involved in this cross-sectional study, which involves a single visit for blood sampling at five time points.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with type 2 diabetes who are not on insulin therapy.
Not a fit: Patients with other forms of diabetes or those allergic to ingredients in the meal replacement shake may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of insulin production in patients with type 2 diabetes.
How similar studies have performed: While this approach is focused on insulin production capacity, similar studies have shown promise in understanding diabetes management, making this a potentially valuable investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Consent provided 2. Age \>= 18 years. 3. Diagnosed as type 2 diabetes mellitus. 4. Not on insulin therapy. Exclusion Criteria: 1. Diagnosed as another form of diabetes mellitus. 2. Allergic to one or more ingredients in Boost meal replacement shake. 3. Unable to fast since midnight and attend in person for the morning protocol.
Where this trial is running
Ottawa, Ontario
- The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Cathy Sun, MD MSc — Ottawa Hospital Research Institute
- Study coordinator: Cathy Sun, MD MSc
- Email: csun@toh.ca
- Phone: 613-738-8333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.