Cardiovascular DiseasesNCT03948295
Lipid Challenge in Adults
A study testing Lipid Challenge in people with Cardiovascular Diseases, run by Emory University at 1 site in United States.
Trial summary
Participants in this study will have one visit to the Emory University Hospital Clinical Research Unit. Participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen), which provides 50 grams… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Lipid Challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2019to 9 Sep 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- functionally ambulatory
- BMI between >20 to 40 kg/m^2
- available for an 8 hour visit to the Emory University Hospital Clinical Research Center
Who cannot join
- has taken any diabetic or lipid lowering prescription medications within the past 12 months
- history of chronic diseases
- hospitalized within the last year
- currently pregnant
- current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
- current chronic autoimmune or pro-inflammatory disease
Show all 13Show fewer
- history of tuberculosis, HIV, or other chronic infection
- previous diagnosis of type 1 or type 2 diabetes with active treatment with insulin or other glucose lowering medication
- advanced (>= stage 3) renal disease
- recreational or prescription drug or alcohol abuse
- any history of gastrointestinal diseases, including malabsorption
- any history of intolerance to dietary fat
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurements of Lipoproteins, Apolipoproteins and Lipids - Determination of Pre-analytical Variables for Analysis of Blood Collected From Fasting and Post-prandial Subjects
Participants in this study will have one visit to the Emory University Hospital Clinical Research Unit. Participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen), which provides 50 grams of long chain triglycerides per 100 mL. Participants will have 20 mL blood withdrawn at six successive time points over an 8-hour period, where the first time point after fasting (baseline) is followed by 5 time-points after fat consumption. Blood will be analyzed for a wide panel of blood lipids.
Read the detailed description
Cardiovascular disease (CVD) is the leading killer of Americans, accounting more than 800,000 deaths each year. A vital step in reducing the number of heart disease-related deaths in the U.S. is to identify those at probable risk. The Clinical Chemistry Branch (CCB) in the Division of Laboratory Sciences (DLS) at the Centers for Disease Control and Prevention (CDC) has developed advanced analytical methods for assessing the risk for lipid metabolism related diseases, including CVD. CCB of the CDC has developed a comprehensive analytical method to measure levels of protein and lipid constituents of lipoprotein size/density classes (e.g. high-density lipoprotein (HDL), low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) in blood. CCB plans to eventually apply this method in future investigations of cohorts with different CVD states. The measurement of this wide array of CVD-linked biomarkers has the potential to improve the assessment of CVD risk over current clinical methods based on lipoprotein classes.
However, limited information is available about how the advanced tests developed by CCB are affected by blood collection conditions, such as fasting/non-fasting state of the subjects. The purpose of this study is to determine the relative significance of these pre-analytical variables and determine optimal conditions for future cohort studies.
This study will recruit up to 32 healthy individuals, with and without obesity, to participate. The study involves one visit to the Emory University Hospital Clinical Research Unit where participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen; http://www.nutricia.ie/calogen#), which provides 50 grams of long chain triglycerides per 100 mL. Participants will have 20 mL blood withdrawn at six successive time points over an 8-hour period, where the first time point after fasting is followed by 5 time-points after fat (Calogen) consumption. Blood will be analyzed at the CCB for a wide panel of blood lipids and potential biomarkers for CVD.
Specific expected outcomes of the study include the following: 1) Determination of typical intra-individual differences between fasting and post-prandial states; and 2) Changes in the levels of the various analytes after fat consumption will be indicative of inter-individual differences in the rate of triglyceride depletion, and the rate of accumulation/depletion of HDL or LDL of different particle size range and composition. The results will allow the assessment of significant differences in lipid metabolism between individuals with a normal BMI (20 to 25 kg/m^2) versus those with a BMI in the obese range (30-35 kg/m^2).
- Conditions
- Cardiovascular Diseases
- Being tested
- Lipid Challenge
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid ChallengeDietary supplement
Also called Calogen
After fasting for 10 hours, all participants will undergo a lipid challenge with Calogen. Calogen is a commercially available liquid high-energy long chain triglyceride fat emulsion used to fortify foods. Calogen provides 50 grams of long chain triglycerides per 100 mL. Participants must avoid physical activity during the 6 hour study period to avoid changes in metabolism that could affect the results of the study.
| Study group | Role | What they receive |
|---|---|---|
| Lipid Challenge Intervention | Experimental | Participants of all weights will receive the lipid challenge intervention. Receives: Dietary Supplement: Lipid Challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in high-density lipoprotein (HDL) Size
HDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. HDL is considered to be anti-atherogenic because of its ability deplete excess cholesterol accumulating necrotic cores and repair arterial lesions.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in low-density lipoprotein (LDL) Size
LDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. LDL is considered to be atherogenic because it is likely to be trapped inside the intima of blood vessels and arteries and initiate inflammatory response, foam-cell formation, and smooth muscle cell proliferation, leading to development necrotic cores, lesions, plaques and their eventual rupture. Elevated LDL has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with LDL levels in the acceptable range.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Total Cholesterol
Total cholesterol profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Elevated total cholesterol has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with total cholesterol levels in the acceptable range.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Free Cholesterol
Free cholesterol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Free cholesterol is unesterified cholesterol that is circulating in the blood stream.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Cholesterol Ester
Cholesterol ester concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Lipoproteins contain cholesterol ester, and cholesterol ester is associated with atherosclerosis.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Triglycerides
Triglyceride concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Triglycerides peak in serum 2 to 4 hours after a meal and return to a pre-meal state in 6 to 8 hours.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Phosphatidylinositol
Phosphatidylinositol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Phosphatidylethanolamine
Phosphatidylethanolamine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Phosphatidylcholine
Phosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Sphingomyelin
Sphingomyelin concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Lysophosphatidylcholine
Lysophosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein AI
Apolipoprotein AI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein AII
Apolipoprotein AII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein AIV
Apolipoprotein AIV concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein B
Apolipoprotein B concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein CI
Apolipoprotein CI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein CII
Apolipoprotein CII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein CIII
Apolipoprotein CIII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Apolipoprotein E
Apolipoprotein E concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Lecithin-Cholesterol Acyltransferase
Lecithin-cholesterol acyltransferase concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Cholesterol Ester Transfer Protein
Cholesterol ester transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Lipoprotein (a)
Lipoprotein (a) concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Phospholipid Transfer Protein
Phospholipid transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Serum Paraoxonase/arylesterase 1
Serum paraoxonase/arylesterase 1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Serum Amyloid A1
Serum amyloid A1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Change in Serum Amyloid A4
Serum amyloid A4 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Measured: Hours 0, 0.5, 1, 2, 4, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start29 Aug 2019
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Thomas R. Ziegler, Emory University
- Investigators
- Thomas R Ziegler, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948295
- Sponsor's protocol ID
- IRB00107183
- Status last verified
- Apr 2023
- First submitted
- 10 May 2019
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurements of Lipoproteins, Apolipoproteins and Lipids - Determination of Pre-analytical Variables for Analysis of Blood Collected From Fasting and Post-prandial Subjects
- ClinicalTrials.gov ID
- NCT03948295
- Acronym / sponsor ID
- IRB00107183
- Conditions
- Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 13 May 2019 (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.
Participants in this study will have one visit to the Emory University Hospital Clinical Research Unit. Participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen), which provides 50 grams of long chain triglycerides per 100 mL. Participants will have 20 mL blood withdrawn at six successive time points over an 8-hour period, where the first time point after fasting (baseline) is followed by 5 time-points after fat consumption. Blood will be analyzed for a wide panel of blood lipids.
Detailed description
Cardiovascular disease (CVD) is the leading killer of Americans, accounting more than 800,000 deaths each year. A vital step in reducing the number of heart disease-related deaths in the U.S. is to identify those at probable risk. The Clinical Chemistry Branch (CCB) in the Division of Laboratory Sciences (DLS) at the Centers for Disease Control and Prevention (CDC) has developed advanced analytical methods for assessing the risk for lipid metabolism related diseases, including CVD. CCB of the CDC has developed a comprehensive analytical method to measure levels of protein and lipid constituents of lipoprotein size/density classes (e.g. high-density lipoprotein (HDL), low-density lipoprotein (LDL) and very low-density lipoprotein (VLDL) in blood. CCB plans to eventually apply this method in future investigations of cohorts with different CVD states. The measurement of this wide array of CVD-linked biomarkers has the potential to improve the assessment of CVD risk over current clinical methods based on lipoprotein classes.
However, limited information is available about how the advanced tests developed by CCB are affected by blood collection conditions, such as fasting/non-fasting state of the subjects. The purpose of this study is to determine the relative significance of these pre-analytical variables and determine optimal conditions for future cohort studies.
This study will recruit up to 32 healthy individuals, with and without obesity, to participate. The study involves one visit to the Emory University Hospital Clinical Research Unit where participants will consume, over 5 minutes, a single standardized fat challenge (100 grams), using a commercially available liquid high-energy long chain triglyceride fat emulsion (Calogen; http://www.nutricia.ie/calogen#), which provides 50 grams of long chain triglycerides per 100 mL. Participants will have 20 mL blood withdrawn at six successive time points over an 8-hour period, where the first time point after fasting is followed by 5 time-points after fat (Calogen) consumption. Blood will be analyzed at the CCB for a wide panel of blood lipids and potential biomarkers for CVD.
Specific expected outcomes of the study include the following: 1) Determination of typical intra-individual differences between fasting and post-prandial states; and 2) Changes in the levels of the various analytes after fat consumption will be indicative of inter-individual differences in the rate of triglyceride depletion, and the rate of accumulation/depletion of HDL or LDL of different particle size range and composition. The results will allow the assessment of significant differences in lipid metabolism between individuals with a normal BMI (20 to 25 kg/m^2) versus those with a BMI in the obese range (30-35 kg/m^2).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipid Challenge Intervention | Experimental | Dietary Supplement: Lipid ChallengeParticipants of all weights will receive the lipid challenge intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- functionally ambulatory
- BMI between >20 to 40 kg/m^2
- available for an 8 hour visit to the Emory University Hospital Clinical Research Center
Key exclusion criteria (13 listed)
- has taken any diabetic or lipid lowering prescription medications within the past 12 months
- history of chronic diseases
- hospitalized within the last year
- currently pregnant
- current active malignant neoplasm or history of malignancy (other than localized basal cell cancer of the skin) during the previous 5 years
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 |
|---|---|---|
| Lipid ChallengeAlso: CalogenAfter fasting for 10 hours, all participants will undergo a lipid challenge with Calogen. Calogen is a commercially available liquid high-energy long chain triglyceride fat emulsion used to fortify foods. Calogen provides 50 grams of long chain triglycerides per 100 mL. Participants must avoid physical activity during the 6 hour study period to avoid changes in metabolism that could affect the results of the study. | Dietary supplement | Lipid Challenge Intervention |
Primary outcome
Change in high-density lipoprotein (HDL) Size
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
HDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. HDL is considered to be anti-atherogenic because of its ability deplete excess cholesterol accumulating necrotic cores and repair arterial lesions.
Change in low-density lipoprotein (LDL) Size
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
LDL concentration size profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. LDL is considered to be atherogenic because it is likely to be trapped inside the intima of blood vessels and arteries and initiate inflammatory response, foam-cell formation, and smooth muscle cell proliferation, leading to development necrotic cores, lesions, plaques and their eventual rupture. Elevated LDL has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with LDL levels in the acceptable range.
Change in Total Cholesterol
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Total cholesterol profiles for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Elevated total cholesterol has been thought to contribute to atherosclerotic events, however, research has also observed coronary events occurring in individuals with total cholesterol levels in the acceptable range.
Change in Free Cholesterol
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Free cholesterol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Free cholesterol is unesterified cholesterol that is circulating in the blood stream.
Change in Cholesterol Ester
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Cholesterol ester concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Lipoproteins contain cholesterol ester, and cholesterol ester is associated with atherosclerosis.
Change in Triglycerides
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Triglyceride concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI. Triglycerides peak in serum 2 to 4 hours after a meal and return to a pre-meal state in 6 to 8 hours.
Change in Phosphatidylinositol
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Phosphatidylinositol concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Phosphatidylethanolamine
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Phosphatidylethanolamine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Phosphatidylcholine
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Phosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Sphingomyelin
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Sphingomyelin concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Lysophosphatidylcholine
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Lysophosphatidylcholine concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein AI
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein AI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein AII
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein AII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein AIV
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein AIV concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein B
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein B concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein CI
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein CI concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein CII
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein CII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein CIII
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein CIII concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Apolipoprotein E
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Apolipoprotein E concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Lecithin-Cholesterol Acyltransferase
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Lecithin-cholesterol acyltransferase concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Cholesterol Ester Transfer Protein
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Cholesterol ester transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Lipoprotein (a)
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Lipoprotein (a) concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Phospholipid Transfer Protein
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Phospholipid transfer protein concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Serum Paraoxonase/arylesterase 1
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Serum paraoxonase/arylesterase 1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Serum Amyloid A1
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Serum amyloid A1 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
Change in Serum Amyloid A4
Time frame: Hours 0, 0.5, 1, 2, 4, and 6
Serum amyloid A4 concentration for each time-point will be compared between participants with normal BMI and participants with obese range BMI.
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 1 May 2023.
- Individual participant dataSharing planned: No
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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.
Thomas R Ziegler, MD principal investigator
Emory 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 Lipid Challenge in people with Cardiovascular Diseases, run by Emory 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 3 inclusion and 13 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 1 May 2023. 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?
Change in high-density lipoprotein (HDL) Size (time frame: Hours 0, 0.5, 1, 2, 4, and 6). The study lists 26 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 1 May 2023.