Overweight and ObesityNCT03367598
Longitudinal Interaction Between APOA5 -1131T>C and Overweight Accelerates Arterial Stiffness
An observational study of Overweight and Obesity, run by Yonsei University.
Trial summary
The aim of this study is to evaluate whether the longitudinal interaction between APOA5 -1131C variants and overweight could accelerate age-related increases in arterial stiffness and circulating triglycerides in healthy subjects. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- rs662799 (APOA5 -1131T>C)
- How many people
- 503 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2008to 31 Dec 2013
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We performed a 3-year prospective cohort study that included 800 heathy subjects (30-65 years old), of these, 503 nondiabetic and nonobese individuals were finally selected.
Who may be able to join
- Nondiabetic (fasting serum glucose concentration < 126 mg/dL)
- Nonobese (BMI ≥ 25 kg/m2)
Who cannot join
- Current and/or past history of cardiovascular disease
- Diabetes mellitus (fasting glucose levels ≥126 mg/dL)
- Abnormal liver or renal function
- Thyroid or pituitary disease
- Pregnancy or lactation
- Regular use of any medication
About this study
Official title: Longitudinal Interaction Between APOA5 -1131T>C and Overweight
The aim of this study is to evaluate whether the longitudinal interaction between APOA5 -1131C variants and overweight could accelerate age-related increases in arterial stiffness and circulating triglycerides in healthy subjects.
- Conditions
- Overweight and Obesity
- Being tested
- rs662799 (APOA5 -1131T>C)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rs662799 (APOA5 -1131T>C)Genetic
Among the 349 normal-weight individuals, 168 were homozygous (TT) for the T allele, 155 were heterozygous for the C allele (TC) and 26 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism. Among the 154 overweight individuals, 68 were homozygous (TT) for the T allele, 75 were heterozygous for the C allele (TC) and 11 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism.
| Study group | Role | What they receive |
|---|---|---|
| Normal weight | nondiabetic and nonobese individuals (18.5 kg/m2 ≤ BMI < 25 kg/m2, n=349) Receives: Genetic: rs662799 (APOA5 -1131T>C) | |
| Overweight | nondiabetic and nonobese individuals (25 kg/m2 ≤ BMI < 30 kg/m2, n=154) Receives: Genetic: rs662799 (APOA5 -1131T>C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachial-ankle PWV (baPWV)
cm/s
Measured: at baseline
Brachial-ankle PWV (baPWV)
cm/s
Measured: 3-year follow-up
Secondary outcomes (2)
Triglyceride
mg/dL
Measured: at baseline
Triglyceride
mg/dL
Measured: 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Jan 2008
- Primary completion1 Dec 2013
- Study completion31 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Ho Lee, Yonsei University
- Investigators
- Jong Ho Lee, PhD, Principal investigator, Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367598
- Sponsor's protocol ID
- PA_fu_APOA5_rs662799
- Status last verified
- Dec 2017
- First submitted
- 4 Dec 2017
- Last updated
- 8 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Interaction Between APOA5 -1131T>C and Overweight
- ClinicalTrials.gov ID
- NCT03367598
- Acronym / sponsor ID
- PA_fu_APOA5_rs662799
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 1 Dec 2013 (actual)
- Study completion
- 31 Dec 2013 (actual)
- First posted
- 8 Dec 2017 (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.
The aim of this study is to evaluate whether the longitudinal interaction between APOA5 -1131C variants and overweight could accelerate age-related increases in arterial stiffness and circulating triglycerides in healthy subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | Genetic: rs662799 (APOA5 -1131T>C)nondiabetic and nonobese individuals (18.5 kg/m2 ≤ BMI < 25 kg/m2, n=349) |
| Overweight | – | Genetic: rs662799 (APOA5 -1131T>C)nondiabetic and nonobese individuals (25 kg/m2 ≤ BMI < 30 kg/m2, n=154) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We performed a 3-year prospective cohort study that included 800 heathy subjects (30-65 years old), of these, 503 nondiabetic and nonobese individuals were finally selected.
Key inclusion criteria (2 listed)
- Nondiabetic (fasting serum glucose concentration < 126 mg/dL)
- Nonobese (BMI ≥ 25 kg/m2)
Key exclusion criteria (6 listed)
- Current and/or past history of cardiovascular disease
- Diabetes mellitus (fasting glucose levels ≥126 mg/dL)
- Abnormal liver or renal function
- Thyroid or pituitary disease
- Pregnancy or lactation
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 |
|---|---|---|
| rs662799 (APOA5 -1131T>C)Among the 349 normal-weight individuals, 168 were homozygous (TT) for the T allele, 155 were heterozygous for the C allele (TC) and 26 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism. Among the 154 overweight individuals, 68 were homozygous (TT) for the T allele, 75 were heterozygous for the C allele (TC) and 11 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism. | Genetic | Normal weight, Overweight |
Primary outcome
Brachial-ankle PWV (baPWV)
Time frame: at baseline
cm/s
Brachial-ankle PWV (baPWV)
Time frame: 3-year follow-up
cm/s
2 secondary outcomes
Triglyceride
Time frame: at baseline
Triglyceride
Time frame: 3-year follow-up
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 8 Dec 2017.
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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.
Jong Ho Lee, PhD principal investigator
Dept. of Food and Nutrition, Colleage of Human Ecology, Yonsei University
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Yonsei University.
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 6 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Brachial-ankle PWV (baPWV) (time frame: at baseline). 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 8 Dec 2017.