DiabetesNCT01972542
The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk
A study testing Oral fat tolerance test in people with Diabetes and Prediabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The hypertriglyceridemia at fasting status has been known to be an important risk factor for cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an attention as a superior predictor of CVD because of non-fasting state for more than 12 hours and importance of triglyceride-rich… Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Prediabetes
- What is being tested?
- Oral fat tolerance test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Aug 2015
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age : 19 ~ 70 yrs
- Type 2 diabetes : HbA1c <10%
- Prediabetic state : HbA1c 5.7~6.4%
Who cannot join
- Type 1 diabetes, secondary diabetes
- dipeptidyl peptidase-4 -inhibitor, glucagon-like peptide-1 agonist, thiazolidinediones users
- Thyroid disease with abnormal thyroid function test
- Liver disease with abnormal liver function test
- severe kidney disease
- pregnant or lactating women
- current smoker
- severe obesity
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, 463-707
About this study
Official title: The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk in Healthy People, Impaired Glucose Tolerance and Type 2 Diabetes
The hypertriglyceridemia at fasting status has been known to be an important risk factor for cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an attention as a superior predictor of CVD because of non-fasting state for more than 12 hours and importance of triglyceride-rich lipoprotein.
We aim to investigate the relationship of postprandial triglyceride after fat tolerance test and intima-medial thickness and to suggest normal reference of postprandial triglyceride after fat tolerance test. In addition, we evaluate the correlation of postprandial triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate clinical importance of postprandial triglyceride in assessment of cardiovascular risk.
- Conditions
- Diabetes, Prediabetes
- Being tested
- Oral fat tolerance test
- Keywords
- Postprandial period, triglyceride, Diabetes mellitus, type 2, Prediabetic state
- Medical subject headings
- Diabetes Mellitus, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral fat tolerance testDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Type 2 DM | Active comparator | Intervention : Oral fat tolerance test
well or moderately controlled type 2 diabetes mellitus (HbA1c < 10%) No dipeptidyl peptidase-4 -inhibitor, Glucagon-like peptide-1 agonist, thiazolidinediones Receives: Dietary Supplement: Oral fat tolerance test |
| Prediabetes | Active comparator | Intervention : Oral fat tolerance test
Glucose 140-199 mg/dL after 75g oral glucose tolerance test HbA1c 5.7-6.4% Receives: Dietary Supplement: Oral fat tolerance test |
| Normal glucose tolerance | Sham comparator | Intervention : Oral fat tolerance test
No impaired fasting glucose and impaired glucose tolerance Receives: Dietary Supplement: Oral fat tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Triglyceride
Blood sample : drawn by a catheter before the meal and every 1 hour after meal over the 8-hour period
Measured: 8 hours
Secondary outcomes (1)
Changes of incretin
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD, MPH, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972542
- Sponsor's protocol ID
- SNUBH-ENDO4
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2013
- Last updated
- 27 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Postprandial Triglyceride for Assessment of Cardiovascular Risk in Healthy People, Impaired Glucose Tolerance and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01972542
- Acronym / sponsor ID
- SNUBH-ENDO4
- Conditions
- Diabetes, Prediabetes
- Keywords
- Postprandial period, triglyceride, Diabetes mellitus, type 2, Prediabetic state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Oct 2013 (estimated)
- 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.
The hypertriglyceridemia at fasting status has been known to be an important risk factor for cardiovascular disease (CVD). Recently, postprandial triglyceride (TG) levels draw an attention as a superior predictor of CVD because of non-fasting state for more than 12 hours and importance of triglyceride-rich lipoprotein.
We aim to investigate the relationship of postprandial triglyceride after fat tolerance test and intima-medial thickness and to suggest normal reference of postprandial triglyceride after fat tolerance test. In addition, we evaluate the correlation of postprandial triglyceride and incretin secretion after fat tolerance test Ultimately, we want to estimate clinical importance of postprandial triglyceride in assessment of cardiovascular risk.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 DM | Active comparator | Dietary Supplement: Oral fat tolerance testIntervention : Oral fat tolerance test well or moderately controlled type 2 diabetes mellitus (HbA1c < 10%) No dipeptidyl peptidase-4 -inhibitor, Glucagon-like peptide-1 agonist, thiazolidinediones |
| Prediabetes | Active comparator | Dietary Supplement: Oral fat tolerance testIntervention : Oral fat tolerance test Glucose 140-199 mg/dL after 75g oral glucose tolerance test HbA1c 5.7-6.4% |
| Normal glucose tolerance | Sham comparator | Dietary Supplement: Oral fat tolerance testIntervention : Oral fat tolerance test No impaired fasting glucose and impaired glucose tolerance |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age : 19 ~ 70 yrs
- Type 2 diabetes : HbA1c <10%
- Prediabetic state : HbA1c 5.7~6.4%
Key exclusion criteria (8 listed)
- Type 1 diabetes, secondary diabetes
- dipeptidyl peptidase-4 -inhibitor, glucagon-like peptide-1 agonist, thiazolidinediones users
- Thyroid disease with abnormal thyroid function test
- Liver disease with abnormal liver function test
- severe kidney disease
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 |
|---|---|---|
| Oral fat tolerance test | Dietary supplement | Normal glucose tolerance, Prediabetes, Type 2 DM |
Primary outcome
Changes of Triglyceride
Time frame: 8 hours
Blood sample : drawn by a catheter before the meal and every 1 hour after meal over the 8-hour period
1 secondary outcome
Changes of incretin
Time frame: 8 hours
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 27 Oct 2015.
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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.
Soo Lim, MD, MPH, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral fat tolerance test in people with Diabetes and Prediabetes, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 8 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 27 Oct 2015. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Changes of Triglyceride (time frame: 8 hours). 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 27 Oct 2015.