Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Boost Original meal replacement shake

• Registration Number: NCT06462170
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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. 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 Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-07
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-17
• Study Start: 2024-06-24
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-06-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Consent provided
2. Age >= 18 years.
3. Diagnosed as type 2 diabetes mellitus.
4. Not on insulin therapy.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pancreatic insulin production after drinking meal replacement shake	Boost Original meal replacement shake	Nutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity.

Primary Outcome Measures

Name	Time	Method
Pancreatic insulin production capacity (PIPC) represented by the participant's insulin and C-peptide levels after drinking the meal replacement shake.	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.

Secondary Outcome Measures

Name	Time	Method
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.	12 months	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.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada