DyslipidemiasNCT04437459
The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
A study testing High-fat shake and Pure glucose solution in people with Dyslipidemias and Metabolic Syndrome, run by Oklahoma State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias, Metabolic Syndrome
- What is being tested?
- High-fat shake and Pure glucose solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free of chronic disease
- Normal (healthy) fasting glucose and triglycerides
Who cannot join
- Presence of pace-maker
- Pregnant
- Using tobacco products
- Using medications or dietary supplements that could modify primary outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University
Stillwater, Oklahoma, 74078-6104
About this study
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.
- Conditions
- Dyslipidemias, Metabolic Syndrome
- Being tested
- High-fat shake, Pure glucose solution
- Medical subject headings
- Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fat shakeOther
Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.
Pure glucose solutionOther
Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated Fat Tolerance Test | Experimental | Not described Receives: Other: High-fat shake |
| Oral Glucose Tolerance Test | Active comparator | Not described Receives: Other: Pure glucose solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The two glucose tolerance tests are separated by 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start8 Oct 2018
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam R Emerson, PhD, Principal investigator, Oklahoma State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437459
- Sponsor's protocol ID
- HS1844
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reproducibility and Clinical Utility of an Abbreviated Fat Tolerance Test
- ClinicalTrials.gov ID
- NCT04437459
- Acronym / sponsor ID
- HS1844
- Conditions
- Dyslipidemias, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oklahoma State UniversityUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abbreviated Fat Tolerance Test | Experimental | Other: High-fat shake |
| Oral Glucose Tolerance Test | Active comparator | Other: Pure glucose solution |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Free of chronic disease
- Normal (healthy) fasting glucose and triglycerides
Key exclusion criteria (4 listed)
- Presence of pace-maker
- Pregnant
- Using tobacco products
- Using medications or dietary supplements that could modify primary outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fat shakeParticipant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides. | Other | Abbreviated Fat Tolerance Test |
| Pure glucose solutionParticipant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose. | Other | Oral Glucose Tolerance Test |
Primary outcome
Reliability of the Change in Triglycerides after a High-Fat Meal
Time frame: The two fat tolerance tests are separated by 1 week.
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
Time frame: The two glucose tolerance tests are separated by 1 week.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam R Emerson, PhD principal investigator
Oklahoma State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fat shake and Pure glucose solution in people with Dyslipidemias and Metabolic Syndrome, run by Oklahoma State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reliability of the Change in Triglycerides after a High-Fat Meal (time frame: The two fat tolerance tests are separated by 1 week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.