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Trial record 3 of 1107 for:    Area Under Curve AND insulin

Saliva Insulin Responses to a Standardized Meal Tolerance Test in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04309071
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborators:
Mitacs
Core-Health Technologies Inc.
Information provided by (Responsible Party):
Jonathan Little, University of British Columbia

Brief 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).

Condition or disease Intervention/treatment Phase
Diet Modification Insulin Resistance Hyperinsulinemia Other: Dietary intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309071


Locations
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Canada, British Columbia
University of British Columbia Okanagan Recruiting
Kelowna, British Columbia, Canada, V1V 3G1
Contact: Jonathan Little, PhD    2508079876    jonathan.little@ubc.ca   
Contact    2508079876    jonathan.little@ubc.ca   
Sponsors and Collaborators
University of British Columbia
Mitacs
Core-Health Technologies Inc.
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Responsible Party: Jonathan Little, Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04309071    
Other Study ID Numbers: H18-02699
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Little, University of British Columbia:
Salivary insulin
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases