Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study

NCT ID: NCT06462170

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-24
• Study Completion Date: 2025-09-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pancreatic insulin production after drinking meal replacement shake

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

Group Type: EXPERIMENTAL

Boost Original meal replacement shake

Intervention Type: DIETARY_SUPPLEMENT

One bottle of Boost Original meal replacement shake.

Interventions

Boost Original meal replacement shake

One bottle of Boost Original meal replacement shake.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cathy Sun, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Cathy Sun, MD MSc

Role: CONTACT

csun@toh.ca

613-738-8333

Facility Contacts

Cathy J Sun, MD MSc

Role: primary

Other Identifiers

20240236-01H

Identifier Type: -

Identifier Source: org_study_id