ObesityNCT00624104
VLDL-triglyceride Under Acute Hyperinsulinaemia
An observational study of Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate and compare the lipid metabolism in lean and obese individuals. We want to investigate the effect of postprandial hyperinsulinaemia on VLDL-triglyceride metabolism Read more about this study
- Who is it for?
- Ages 20 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Food (fat free meal)
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to Dec 2010
- 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 20 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males with diabetes from departments out-patient clinic. Control group of healthyt volunteers
Who may be able to join
- Written consent
Who cannot join
- Known diseases
- Alcohol abuse
- Smoker
- Regular use of medicine
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate and compare the lipid metabolism in lean and obese individuals. We want to investigate the effect of postprandial hyperinsulinaemia on VLDL-triglyceride metabolism
- Conditions
- Obesity
- Being tested
- Food (fat free meal)
- Keywords
- VLDL, Kinetics, Hyperinsulinaemia, Obesity
- Medical subject headings
- Obesity, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food (fat free meal)Dietary supplement
Fat free meal (40% of REE)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Lean male Receives: Dietary Supplement: Food (fat free meal) | |
| 2 | Males with type 2 diabetes Receives: Dietary Supplement: Food (fat free meal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VLDL metabolism
Measured: Few hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624104
- Sponsor's protocol ID
- ES-0001
- Status last verified
- Nov 2011
- First submitted
- 18 Feb 2008
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VLDL-triglyceride Under Acute Hyperinsulinaemia
- ClinicalTrials.gov ID
- NCT00624104
- Acronym / sponsor ID
- ES-0001
- Conditions
- Obesity
- Keywords
- VLDL, Kinetics, Hyperinsulinaemia, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 26 Feb 2008 (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 the study is to investigate and compare the lipid metabolism in lean and obese individuals. We want to investigate the effect of postprandial hyperinsulinaemia on VLDL-triglyceride metabolism
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Dietary Supplement: Food (fat free meal)Lean male |
| 2 | – | Dietary Supplement: Food (fat free meal)Males with type 2 diabetes |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males with diabetes from departments out-patient clinic. Control group of healthyt volunteers
Key inclusion criteria (1 listed)
- Written consent
Key exclusion criteria (4 listed)
- Known diseases
- Alcohol abuse
- Smoker
- Regular use of medicine
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 |
|---|---|---|
| Food (fat free meal)Fat free meal (40% of REE) | Dietary supplement | 1, 2 |
Primary outcome
VLDL metabolism
Time frame: Few 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 7 Nov 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Aarhus at 1 site in Denmark.
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 1 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 7 Nov 2011. 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 Denmark. 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?
VLDL metabolism (time frame: Few 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 7 Nov 2011.