Back to resultsThe Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
Primary Purpose
Dyslipidemias, Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-fat shake
Pure glucose solution
Sponsored by
About this trial
This is an interventional screening trial for Dyslipidemias
Eligibility Criteria
Inclusion Criteria:
- Free of chronic disease
- Normal (healthy) fasting glucose and triglycerides
Exclusion Criteria:
- Presence of pace-maker
- Pregnant
- Using tobacco products
- Using medications or dietary supplements that could modify primary outcomes
Sites / Locations
- Oklahoma State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Abbreviated Fat Tolerance Test
Oral Glucose Tolerance Test
Arm Description
Outcomes
Primary Outcome Measures
Reliability of the Change in Triglycerides after a High-Fat Meal
Participants complete two fat tolerance tests. In each test, triglycerides are measured in blood immediately before and 4 hours after consumption of a high-fat meal. The reliability/agreement in measuring the triglyceride change between the 2 tests is being determined.
Reliability of the Change in Glucose after Ingestion of a Glucose Solution
Participants complete two glucose tolerance tests. In each test, glucose is measured in blood immediately before and 2 hours after consumption of a pure glucose solution. The reliability/agreement in measuring the glucose change between the 2 tests is being determined.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04437459
Brief Title
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
Official Title
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oklahoma State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to evaluate the reliability of a shortened fat tolerance test ("abbreviated fat tolerance test", or "AFTT") for measuring post-meal lipids in human blood. The reliability of the triglyceride results in this test are compared to the reliability of the glucose results from an oral glucose tolerance test (OGTT), a widely-used and clinically accepted metabolic test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias, Metabolic Syndrome
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abbreviated Fat Tolerance Test
Arm Type
Experimental
Arm Title
Oral Glucose Tolerance Test
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
High-fat shake
Intervention Description
Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.
Intervention Type
Other
Intervention Name(s)
Pure glucose solution
Intervention Description
Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.
Primary Outcome Measure Information:
Title
Reliability of the Change in Triglycerides after a High-Fat Meal
Description
Participants complete two fat tolerance tests. In each test, triglycerides are measured in blood immediately before and 4 hours after consumption of a high-fat meal. The reliability/agreement in measuring the triglyceride change between the 2 tests is being determined.
Time Frame
The two fat tolerance tests are separated by 1 week.
Title
Reliability of the Change in Glucose after Ingestion of a Glucose Solution
Description
Participants complete two glucose tolerance tests. In each test, glucose is measured in blood immediately before and 2 hours after consumption of a pure glucose solution. The reliability/agreement in measuring the glucose change between the 2 tests is being determined.
Time Frame
The two glucose tolerance tests are separated by 1 week.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Free of chronic disease
Normal (healthy) fasting glucose and triglycerides
Exclusion Criteria:
Presence of pace-maker
Pregnant
Using tobacco products
Using medications or dietary supplements that could modify primary outcomes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam R Emerson, PhD
Organizational Affiliation
Oklahoma State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma State University
City
Stillwater
State/Province
Oklahoma
ZIP/Postal Code
74078-6104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
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