HealthyNCT00893893
Very-low-density-lipoprotein Triglyceride (VLDL-TG) Uptake in Visceral Fat
An observational study of Healthy and Obesity, run by University of Aarhus at 1 site in Denmark.
Trial summary
Purpose: To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- May 2009to Jan 2011
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy volunteers
Who may be able to join
- Healthy
- Age: 20-50 years
- Premenopausal
Who cannot join
- Smoking
- Alcohol abuse
- Use of medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Very-low-density-lipoprotein Triglyceride(VLDL-TG) Uptake in Visceral Fat
Purpose:
To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals
- Keywords
- Obesity, Lipid metabolism, VLDL
- Medical subject headings
- Obesity
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 |
|---|---|---|
| 1 | Lean premenopausal women | |
| 2 | Visceral obese premenopausal women |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMay 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esben Søndergaard, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893893
- Sponsor's protocol ID
- ES-0003
- Status last verified
- Aug 2011
- First submitted
- 5 May 2009
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sondergaard E, Nellemann B, Sorensen LP, Gormsen LC, Christiansen JS, Ernst E, Dueholm M, Nielsen S. Similar VLDL-TG storage in visceral and subcutaneous fat in obese and lean women. Diabetes. 2011 Nov;60(11):2787-91. doi: 10.2337/db11-0604. Epub 2011 Sep 12.
PubMed 21911742
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very-low-density-lipoprotein Triglyceride(VLDL-TG) Uptake in Visceral Fat
- ClinicalTrials.gov ID
- NCT00893893
- Acronym / sponsor ID
- ES-0003
- Keywords
- Obesity, Lipid metabolism, VLDL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 6 May 2009 (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.
Purpose:
To investigate the uptake of VLDL-TG in visceral fat in lean and overweight individuals
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Lean premenopausal women |
| 2 | – | –Visceral obese premenopausal women |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Healthy
- Age: 20-50 years
- Premenopausal
Key exclusion criteria (3 listed)
- Smoking
- Alcohol abuse
- Use of medications
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
Not reported in the source record.
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 25 Aug 2011.
- Derived from this study: PubMed 21911742Sondergaard E, Nellemann B, Sorensen LP, Gormsen LC, Christiansen JS, Ernst E, Dueholm M, Nielsen S. Similar VLDL-TG storage in visceral and subcutaneous fat in obese and lean women. Diabetes. 2011 Nov;60(11):2787-91. doi: 10.2337/db11-0604. Epub 2011 Sep 12.
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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 Healthy and 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 3 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 25 Aug 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00893893, which also lists 1 linked publication.
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 25 Aug 2011.