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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
The Ottawa Hospital
Ottawa, Ontario, Canada
Start Date
June 24, 2024
Primary Completion Date
June 30, 2025
Completion Date
September 30, 2025
Last Updated
June 26, 2024
90
ESTIMATED participants
Boost Original meal replacement shake
DIETARY_SUPPLEMENT
Lead Sponsor
Ottawa Hospital Research Institute
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06671587