Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Insulin Resistance Clinical Trial

Official title:

Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04309071
• Other study ID #: H18-02699
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2019
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet Modification
• Hyperinsulinemia
• Hyperinsulinism
• Insulin Resistance

Intervention

Other:
• Dietary intervention
Salivary insulin responses to a standardized mixed meal

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Core-Health Technologies Inc., Mitacs

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Saliva insulin area under the curve	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)
Primary	Saliva insulin at different time points	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	Glucose area under the curve	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)
Secondary	Glucose	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)