Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans
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|ClinicalTrials.gov Identifier: NCT04309071|
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diet Modification Insulin Resistance Hyperinsulinemia||Other: Dietary intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans|
|Actual Study Start Date :||January 4, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
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.
Other: Dietary intervention
Salivary insulin responses to a standardized mixed meal
- 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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309071