HyperlipidemiaNCT01571609
Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
A study testing first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer in people with Hyperlipidemia and Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia, Diabetes Mellitus, Metabolic Syndrome
- What is being tested?
- first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2012to Nov 2014
- Phase
- Interventional
- 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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- 18-70 years of age
- Member of Biobank Vejle
- BMI<30
Who cannot join
- Diabetes mellitus
- Severe illness
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medicinsk forskningslaboratorium, Aarhus Universitet
Aarhus, 8000
About this study
The purpose of the present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters.
- Being tested
- first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer
- Medical subject headings
- Hyperlipidemias, Diabetes Mellitus, Metabolic Syndrome, Hypertension, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracerOther
FPIR: intravenous infusion of 20 % glucose 0.3 mg/kg in 2 minutes followed by blood sampling at times 0, 2, 4, 6, 8, and 10. Duration 10 minutes.
HEC: intravenous infusion of actrapid 1mU/kg/minute, simultaneous infusion of 20 % glucose at variable rate to reach plasma blood glucose level of 5 mmol/L. Duration 120 minutes
Glucose tracer: bolus of 3H3glucose (12µCi) followed by infusion of 3H3glucose (0,12 µCi/min). Duration 120 minutes.
Palmitate tracer:[9,10-3H]-palmitate 0,3 µCi/min. Duration 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Carriers | Experimental | Not described Receives: Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer |
| Non-carriers | Experimental | Not described Receives: Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin secretion
Estimation of first phase insulin secretion
Measured: 10 minutes
Secondary outcomes (7)
Insulin resistance
Estimation of insulin resistance using hyperinsulinemic euglycemic clamp and glucose and lipid tracers
Measured: 240 minutes
body composition
Evaluation of body composition using Dxa scan and MRI scan
Measured: 60 minutes
atherosclerosis
Evaluation of presence and severity of atherosclerosis using ultrasound scan of the common carotide artery
Measured: 30 minutes
biochemical blood profiling
Various tests run on blood samples
Measured: at baseline
Insulin resistance
Biopsi from muscle and adipose tissue performed at baseline and during clamp study.
Measured: 60 minutes
Blood pressure
Measurement of blood pressure every 20. minutes/24 hours
Measured: 24 hours
Indirect calorimetry
Estimation of resting energy expenditure and respiratory quotient
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Aarhus University Hospital, Vejle Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Steno Diabetes Center Copenhagen, University of Copenhagen
- Responsible party
- Principal investigator, Julie Støy, University of Aarhus
- Investigators
- Niels Møller, Professor, Principal investigator, University of AarhusOluf B Pedersen, Professor, Principal investigator, Steno Diabetes Center CopenhagenTorben Hansen, Professor, Principal investigator, Steno Diabetes Center CopenhagenJørgen Rungby, Professor, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571609
- Sponsor's protocol ID
- 1-10-72-113-12
- Status last verified
- Dec 2014
- First submitted
- 3 Apr 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stoy J, Kampmann U, Mengel A, Magnusson NE, Jessen N, Grarup N, Rungby J, Stodkilde-Jorgensen H, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N. Reduced CD300LG mRNA tissue expression, increased intramyocellular lipid content and impaired glucose metabolism in healthy male carriers of Arg82Cys in CD300LG: a novel genometabolic cross-link between CD300LG and common metabolic phenotypes. BMJ Open Diabetes Res Care. 2015 Aug 26;3(1):e000095. doi: 10.1136/bmjdrc-2015-000095. eCollection 2015.
PubMed 26336608Stoy J, Grarup N, Horlyck A, Ibsen L, Rungby J, Poulsen PL, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N, Kampmann U. Blood pressure levels in male carriers of Arg82Cys in CD300LG. PLoS One. 2014 Oct 14;9(10):e109646. doi: 10.1371/journal.pone.0109646. eCollection 2014.
PubMed 25314291
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Physiology Studies in Carriers of Gene Variant X Conferring Major Risk of CVD-prone Metabolic Disorders
- ClinicalTrials.gov ID
- NCT01571609
- Acronym / sponsor ID
- 1-10-72-113-12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Aarhus University Hospital, Vejle Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Steno Diabetes Center Copenhagen, University of Copenhagen
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 5 Apr 2012 (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 present study is to conduct a thorough and relevant physiology study of carriers and non-carriers of the gene variant X in order to determine the effect of the genetic variant on various metabolic parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carriers | Experimental | Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer |
| Non-carriers | Experimental | Other: first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- 18-70 years of age
- Member of Biobank Vejle
- BMI<30
Key exclusion criteria (2 listed)
- Diabetes mellitus
- Severe illness
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 |
|---|---|---|
| first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracerFPIR: intravenous infusion of 20 % glucose 0.3 mg/kg in 2 minutes followed by blood sampling at times 0, 2, 4, 6, 8, and 10. Duration 10 minutes. HEC: intravenous infusion of actrapid 1mU/kg/minute, simultaneous infusion of 20 % glucose at variable rate to reach plasma blood glucose level of 5 mmol/L. Duration 120 minutes Glucose tracer: bolus of 3H3glucose (12µCi) followed by infusion of 3H3glucose (0,12 µCi/min). Duration 120 minutes. Palmitate tracer:[9,10-3H]-palmitate 0,3 µCi/min. Duration 60 minutes. | Other | Carriers, Non-carriers |
Primary outcome
insulin secretion
Time frame: 10 minutes
Estimation of first phase insulin secretion
7 secondary outcomes
Insulin resistance
Time frame: 240 minutes
body composition
Time frame: 60 minutes
atherosclerosis
Time frame: 30 minutes
biochemical blood profiling
Time frame: at baseline
Insulin resistance
Time frame: 60 minutes
Blood pressure
Time frame: 24 hours
Indirect calorimetry
Time frame: 60 minutes
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 2 Dec 2014.
- Derived from this study: PubMed 26336608Stoy J, Kampmann U, Mengel A, Magnusson NE, Jessen N, Grarup N, Rungby J, Stodkilde-Jorgensen H, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N. Reduced CD300LG mRNA tissue expression, increased intramyocellular lipid content and impaired glucose metabolism in healthy male carriers of Arg82Cys in CD300LG: a novel genometabolic cross-link between CD300LG and common metabolic phenotypes. BMJ Open Diabetes Res Care. 2015 Aug 26;3(1):e000095. doi: 10.1136/bmjdrc-2015-000095. eCollection 2015.
- Derived from this study: PubMed 25314291Stoy J, Grarup N, Horlyck A, Ibsen L, Rungby J, Poulsen PL, Brandslund I, Christensen C, Hansen T, Pedersen O, Moller N, Kampmann U. Blood pressure levels in male carriers of Arg82Cys in CD300LG. PLoS One. 2014 Oct 14;9(10):e109646. doi: 10.1371/journal.pone.0109646. eCollection 2014.
- Project home pageLink provided by the sponsor.
Related trials for Hyperlipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
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.
Niels Møller, Professor principal investigator
University of Aarhus
Oluf B Pedersen, Professor principal investigator
Steno Diabetes Center Copenhagen
Torben Hansen, Professor principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer in people with Hyperlipidemia and Diabetes Mellitus, 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 4 inclusion and 2 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 2 Dec 2014. 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?
insulin secretion (time frame: 10 minutes). 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 NCT01571609, which also lists 2 linked publications.
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 2 Dec 2014.