Type 1 DiabetesNCT01178957
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia
An observational study of Type 1 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to estimate the acute effect of hyperglycemia on Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Hyperglycemia
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Apr 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Study population: Type 1 diabetics
Who may be able to join
- Type 1 diabetes
- Age 18-50 years
Who cannot join
- Smoking
- Alcohol abuse
- Use of medications (except insulin in diabetics)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to estimate the acute effect of hyperglycemia on Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.
- Conditions
- Type 1 Diabetes
- Being tested
- Hyperglycemia
- Keywords
- Type 1 diabetes, Very-Low-Density-Lipoprotein(VLDL), Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperglycemiaOther
Hyperglycemia with a blood glucose of 15 mmol/L
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Not described Receives: Other: Hyperglycemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) secretion
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) kinetics over a single study day
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 posted10 Aug 2010 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
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 Type 1 DiabetesStudies 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
- 8 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
- NCT01178957
- Sponsor's protocol ID
- ES-0004
- Status last verified
- Aug 2013
- First submitted
- 21 Apr 2010
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johansen RF, Sondergaard E, Sorensen LP, Nellemann B, Christiansen JS, Nielsen S. Isolated hyperglycaemia does not increase VLDL-triacylglycerol secretion in type 1 diabetic men. Diabetologia. 2015 Feb;58(2):355-62. doi: 10.1007/s00125-014-3422-6. Epub 2014 Nov 11.
PubMed 25385409
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia
- ClinicalTrials.gov ID
- NCT01178957
- Acronym / sponsor ID
- ES-0004
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Very-Low-Density-Lipoprotein(VLDL), Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Aug 2010 (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 estimate the acute effect of hyperglycemia on Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | Other: Hyperglycemia |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Type 1 diabetics
Key inclusion criteria (2 listed)
- Type 1 diabetes
- Age 18-50 years
Key exclusion criteria (3 listed)
- Smoking
- Alcohol abuse
- Use of medications (except insulin in diabetics)
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 |
|---|---|---|
| HyperglycemiaHyperglycemia with a blood glucose of 15 mmol/L | Other | Type 1 diabetes |
Primary outcome
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) secretion
Time frame: 8 hours
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) kinetics over a single study day
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 Aug 2013.
- Derived from this study: PubMed 25385409Johansen RF, Sondergaard E, Sorensen LP, Nellemann B, Christiansen JS, Nielsen S. Isolated hyperglycaemia does not increase VLDL-triacylglycerol secretion in type 1 diabetic men. Diabetologia. 2015 Feb;58(2):355-62. doi: 10.1007/s00125-014-3422-6. Epub 2014 Nov 11.
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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 Type 1 Diabetes, 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 2 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 7 Aug 2013. 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?
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) secretion (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178957, 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 7 Aug 2013.