Ignite Creation Date:
2024-07-17 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462170
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-07
Brief Title:
Pancreatic Insulin Production Capacity PIPC - a Feasibility Study
Sponsor:
Ottawa Hospital Research Institute
Organization:
Ottawa Hospital Research Institute
Study Overview
Official Title:
The Feasibility of an Innovative Protocol to Demonstrate the Impact of Positive Energy Balance on Pancreatic Insulin Production Capacity PIPC
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPC
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
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 participants pancreatic insulin production capacity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None