Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study

Type 2 Diabetes Clinical Trial

— PIPC  

Official title:

The Feasibility of an Innovative Protocol to Demonstrate the Impact of Positive Energy Balance on Pancreatic Insulin Production Capacity (PIPC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06462170
• Other study ID #: 20240236-01H
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: June 2024
• Source: Ottawa Hospital Research Institute
• Contact: Cathy Sun, MD MSc
• Phone: 613-738-8333
• Email: csun[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: September 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Dietary Supplement:
• Boost Original meal replacement shake
One bottle of Boost Original meal replacement shake.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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