The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedFirst Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedJune 18, 2020
June 1, 2020
10 months
June 15, 2020
June 16, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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.
The two fat tolerance tests are separated by 1 week.
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.
The two glucose tolerance tests are separated by 1 week.
Study Arms (2)
Abbreviated Fat Tolerance Test
EXPERIMENTALOral Glucose Tolerance Test
ACTIVE COMPARATORInterventions
Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.
Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.
Eligibility Criteria
You may qualify if:
- Free of chronic disease
- Normal (healthy) fasting glucose and triglycerides
You may not qualify if:
- Presence of pace-maker
- Pregnant
- Using tobacco products
- Using medications or dietary supplements that could modify primary outcomes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oklahoma State University
Stillwater, Oklahoma, 74078-6104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sam R Emerson, PhD
Oklahoma State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 18, 2020
Study Start
October 8, 2018
Primary Completion
July 31, 2019
Study Completion
July 31, 2019
Last Updated
June 18, 2020
Record last verified: 2020-06