- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04309071
Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
September 27, 2021 updated by: Jonathan Little, University of British Columbia
Recent evidence suggests that hyperinsulinemia (i.e., elevated insulin levels) is the primary causative factor in obesity.
Insulin promotes fat storage and prevents fat breakdown, suggesting that weight loss would be optimized if insulin levels are managed and kept low.
Understanding how different foods impact insulin levels could therefore aid in personalized weight loss (or weight maintenance) advice.
It has been shown that salivary insulin can track plasma insulin following different meals and can delineate between lean and obese people.
Thus, it was suggested that salivary insulin could be a potential surrogate for plasma insulin.
The purpose of this study is to measure fasting saliva insulin, and salivary insulin responses to a standardized meal tolerance test in individuals with different body mass index (BMI).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Kelowna, British Columbia, Canada, V1V 3G1
- Recruiting
- University of British Columbia Okanagan
-
Contact:
- Jonathan Little, PhD
- Phone Number: 2508079876
- Email: jonathan.little@ubc.ca
-
Contact:
- Phone Number: 2508079876
- Email: jonathan.little@ubc.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- non-smoker
- have a body mass index greater than 18.5 kg/m2
- have not been diagnosed with type 2 diabetes or other medical conditions affecting glucose or insulin levels
Exclusion Criteria:
- You have been. diagnosed with diabetes (fasting blood sugar more than 7.0 mmol/l) or any other diagnosed chronic condition that may impact your glucose or insulin levels or the outcomes of this study.
- You take any medication which may affect your glucose and insulin level
- Unable to travel to make your testing appointments.
- Unable to consume the meal tolerance test drink/shake and/or provide finger stick glucose or saliva samples for the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Salivary insulin responses to mixed meal tolerance test
Saliva samples and finger prick glucose will be collected after at least 4 hours of fasting and then at 60 and 90 minutes following ingestion of a standardized meal tolerance test.
|
Salivary insulin responses to a standardized mixed meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Saliva insulin area under the curve
Time Frame: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
|
The saliva insulin concentration measured by enzyme-linked immunosorbent assay - Area under the curve will be measured using the trapezoidal rule.
|
Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
|
Saliva insulin at different time points
Time Frame: Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
|
Saliva insulin will be collected and measured by enzyme-linked immunosorbent assay.
|
Salivary insulin at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose area under the curve
Time Frame: Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
|
Finger prick glucose concentration measured by glucometer - Area under the curve will be measured using the trapezoidal rule.
|
Measured for 90 minutes following the meal (time points: fasting, 60 minutes, and 90 minutes)
|
Glucose
Time Frame: Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
|
Finger prick glucose at different time points will be measured by a glucometer.
|
Finger prick glucose will be measured at fasting (at least 4 hours of fasting), and at 60 and 90 minutes following mixed meal ingestion)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2019
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
September 1, 2022
Study Registration Dates
First Submitted
March 11, 2020
First Submitted That Met QC Criteria
March 11, 2020
First Posted (Actual)
March 16, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H18-02699
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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