Healthy SubjectsNCT01786421
Diurnal Triglyceridemia in Relation to Alcohol Intake
An observational study of Healthy Subjects and Hyperlipidemias, run by Sint Franciscus Gasthuis at 2 sites in Netherlands.
Trial summary
The purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Hyperlipidemias, Type 2 Diabetes Mellitus
- How many people
- 273 participants
- Where
- 2 sitesNetherlands
- Study dates
- Start not givento Dec 2005
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were healthy volunteers or patients with hyperlipidemia or a known medical history of cardiovascular diseases, type 2 diabetes mellitus participating in several clinical studies with the same protocol, aimed to investigate factors influencing postprandial lipemia
Who may be able to join
- Healthy volunteers
- Patients with:
- Hyperlipidemia
- Type 2 Diabetes Mellitus
- Cardiovascular diseases
Who cannot join
- Renal disease
- Liver disease
- Thyroid disease
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Sint Franciscus Gasthuis
Rotterdam, Rotterdam, 10900
Utrecht University Medical Center
Utrecht, Utrecht
About this study
Official title: Observational Study of Diurnal Triglyceridemia in Relation to Alcohol Intake
The purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation.
- Keywords
- Ethanol, Lipemia, Postprandial, Triglyceride
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Type 2, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General population | Healthy volunteers,patients with hyperlipidemia,a known medical history of cardiovascular diseases or type 2 diabetes mellitus. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of diurnal triglyceridemia depend on alcohol intake
Capillary triglyceridemia was measured by a triglyceride testing device on six fixed time-points.
Measured: For 3 days.
Secondary outcomes (1)
Gender differences in diurnal triglyceridemia by alcohol consumption
Measured: For 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Primary completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Franciscus Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Torres do Rego, Sint Franciscus Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786421
- Sponsor's protocol ID
- AlcoholTG_SFG_2013
- Status last verified
- Feb 2013
- First submitted
- 29 Jan 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Diurnal Triglyceridemia in Relation to Alcohol Intake
- ClinicalTrials.gov ID
- NCT01786421
- Acronym / sponsor ID
- AlcoholTG_SFG_2013
- Keywords
- Ethanol, Lipemia, Postprandial, Triglyceride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Sint Franciscus GasthuisUniversity, hospital or other
- Primary completion
- Dec 2005 (actual)
- First posted
- 8 Feb 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 purpose of this study is to determine the impact of alcohol consumption in diurnal triglyceridemia in a free living situation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General population | – | –Healthy volunteers,patients with hyperlipidemia,a known medical history of cardiovascular diseases or type 2 diabetes mellitus. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were healthy volunteers or patients with hyperlipidemia or a known medical history of cardiovascular diseases, type 2 diabetes mellitus participating in several clinical studies with the same protocol, aimed to investigate factors influencing postprandial lipemia
Key inclusion criteria (5 listed)
- Healthy volunteers
- Hyperlipidemia
- Type 2 Diabetes Mellitus
- Cardiovascular diseases
Key exclusion criteria (3 listed)
- Renal disease
- Liver disease
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of diurnal triglyceridemia depend on alcohol intake
Time frame: For 3 days.
Capillary triglyceridemia was measured by a triglyceride testing device on six fixed time-points.
1 secondary outcome
Gender differences in diurnal triglyceridemia by alcohol consumption
Time frame: For 3 days
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 Feb 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Subjects and Hyperlipidemias, run by Sint Franciscus Gasthuis at 2 sites in Netherlands.
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 5 inclusion and 3 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 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Determination of diurnal triglyceridemia depend on alcohol intake (time frame: For 3 days.). 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 Feb 2013.