Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study (PIPC)

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Boost Original meal replacement shake

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cathy Sun, MD MSc; Phone Number: 613-738-8333; Email: csun@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H7W9
      • Recruiting
      • The Ottawa Hospital
      • Contact: Cathy J Sun, MD MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pancreatic insulin production after drinking meal replacement shake; Nutritional intervention, and then blood work will be drawn to measure pancreatic insulin production capacity.	Dietary supplement: Boost Original meal replacement shake; One bottle of Boost Original meal replacement shake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Cathy Sun, MD MSc, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20240236-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No