Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study

Ottawa Hospital Research Institute

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Boost Original meal replacement shake

Study type: Interventional

Funder types: Other

Identifiers

NCT06462170

20240236-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

90 participants in 1 patient group

Pancreatic insulin production after drinking meal replacement shake

Experimental group

Description:

Nutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity.

Treatment:

Dietary Supplement: Boost Original meal replacement shake