Pancreatic Insulin Production Capacity (PIPC) - a Feasibility Study
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consent provided
Age >= 18 years.
Diagnosed as type 2 diabetes mellitus.
Not on insulin therapy.
Disqualifiers
Diagnosed as another form of diabetes mellitus.
Allergic to one or more ingredients in Boost meal replacement shake.
Unable to fast since midnight and attend in person for the morning protocol.
Trial design
Design model
Single group
Treatments tested in this trial
Boost Original meal replacement shake
Dietary supplementOne bottle of Boost Original meal replacement shake.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Pancreatic insulin production after drinking meal replacement shakeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 monthsSecondary outcomes
1
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.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov