Type 2 DiabetesNCT01564550
The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
An observational study of Type 2 Diabetes and Dyslipidemia, run by University of Aarhus at 1 site in Denmark.
Trial summary
In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Dyslipidemia
- What is being tested?
- Insulin, diet and no diet
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Dec 2014
- 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 35 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The type 2 diabetic men will be recruited from the endocrinology ambulatory of Aarhus University hospital. The healthy subjects will be recruited by local advertisement in the city of Aarhus and by national website advertisement.
Who may be able to join
- patients with type 2 diabetes during at least six month or healthy subjects
- male
- BMI 25-36 kg/m2
- age 35-65
Who cannot join
- other diseases (hypertension and hypercholesterolemia tolerated)
- Insulin treatment
- alcohol abuse
- smoking
- medication affecting lipid metabolism apart from statins and antihypertensive drugs paused 2 weeks prior to the study day.
- participation in studies involving radioactive isotopes or larger x-ray investigations within the last six month.
- blood donation within three month.
Trial locations and contacts
1 site in 1 country.
About this study
In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The investigators hypothesis is that the investigators will find an increased VLDL1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where the investigators expect less variance in VLDL production when the subject is given an isocaloric diet.
Read the detailed description
Patients with type 2 diabetes are more likely to suffer from dyslipidemia. Earlier research has shown that these patients have an increased VLDL production and this could be a key factor in dyslipidemia development. Especially the production of VLDL1 seems to be increased where an inhibitory response to insulin is lacking. Further investigation in VLDL1 and VLDL2 kinetics is required.
The investigators wish:
- To extend the method of ex vivo labeling of VLDL-triglyceride, to include separate labeling of VLDL1- and VLDL2-triglyceride for evaluation of the separate lipoprotein subtype kinetics.
- To investigate VLDL1- and VLDL2-triglyceride kinetics in the post absorptive state and under experimental hyperinsulinemia in twelve type 2 diabetic males compared to twelve healthy age, sex, and BMI matched males.
- To investigate the effect of a three day isocaloric diet compared to a non-restricted diet on the day-to-day variation in VLDL1 and VLDL2-triglyceride kinetics in healthy men. The investigators here examine six subjects on two different days who ingest a non-restricted diet and compare this group to six subjects examined on two different days, who have prior ingest a three day isocaloric diet.
- Conditions
- Type 2 Diabetes, Dyslipidemia
- Being tested
- Insulin, diet, no diet
- Keywords
- Type 2 diabetes, Very-low-density-lipoprotein(VLDL), VLDL1, VLDL2, hyperinsulinemia, diet
- Medical subject headings
- Diabetes Mellitus, Type 2, Dyslipidemias, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Actrapid, Novo Nordisk, A10AB01
Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.
insulinDrug
Also called Actrapid, Novo Nordisk, A10AB01
Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.
dietOther
The subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day.
no dietOther
The subjects will ingest a non-restricted diet prior to the study day.
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetes | Not described Receives: Drug: Insulin | |
| healthy subjects | Not described Receives: Drug: insulin; Other: diet; Other: no diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
VLDL1 and VLDL2-triglyceride secretion rate (µmol/min)
VLDL1 and VLDL2 kinetics assessed over a single study day.
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
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 2 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rakel F Johansen, M.D., Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01564550
- Sponsor's protocol ID
- 33046
- Status last verified
- Nov 2012
- First submitted
- 22 Feb 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johansen RF, Sondergaard E, Sorensen LP, Jurik AG, Christiansen JS, Nielsen S. Basal and insulin-regulated VLDL1 and VLDL2 kinetics in men with type 2 diabetes. Diabetologia. 2016 Apr;59(4):833-43. doi: 10.1007/s00125-015-3856-5. Epub 2016 Jan 19.
PubMed 26781548
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
- ClinicalTrials.gov ID
- NCT01564550
- Acronym / sponsor ID
- 33046
- Conditions
- Type 2 Diabetes, Dyslipidemia
- Keywords
- Type 2 diabetes, Very-low-density-lipoprotein(VLDL), VLDL1, VLDL2, hyperinsulinemia, diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Mar 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.
In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The investigators hypothesis is that the investigators will find an increased VLDL1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where the investigators expect less variance in VLDL production when the subject is given an isocaloric diet.
Detailed description
Patients with type 2 diabetes are more likely to suffer from dyslipidemia. Earlier research has shown that these patients have an increased VLDL production and this could be a key factor in dyslipidemia development. Especially the production of VLDL1 seems to be increased where an inhibitory response to insulin is lacking. Further investigation in VLDL1 and VLDL2 kinetics is required.
The investigators wish:
- To extend the method of ex vivo labeling of VLDL-triglyceride, to include separate labeling of VLDL1- and VLDL2-triglyceride for evaluation of the separate lipoprotein subtype kinetics.
- To investigate VLDL1- and VLDL2-triglyceride kinetics in the post absorptive state and under experimental hyperinsulinemia in twelve type 2 diabetic males compared to twelve healthy age, sex, and BMI matched males.
- To investigate the effect of a three day isocaloric diet compared to a non-restricted diet on the day-to-day variation in VLDL1 and VLDL2-triglyceride kinetics in healthy men. The investigators here examine six subjects on two different days who ingest a non-restricted diet and compare this group to six subjects examined on two different days, who have prior ingest a three day isocaloric diet.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes | – | Drug: Insulin |
| healthy subjects | – | Drug: insulin, Other: diet, Other: no diet |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The type 2 diabetic men will be recruited from the endocrinology ambulatory of Aarhus University hospital. The healthy subjects will be recruited by local advertisement in the city of Aarhus and by national website advertisement.
Key inclusion criteria (4 listed)
- patients with type 2 diabetes during at least six month or healthy subjects
- male
- BMI 25-36 kg/m2
- age 35-65
Key exclusion criteria (7 listed)
- other diseases (hypertension and hypercholesterolemia tolerated)
- Insulin treatment
- alcohol abuse
- smoking
- medication affecting lipid metabolism apart from statins and antihypertensive drugs paused 2 weeks prior to the study day.
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 |
|---|---|---|
| InsulinAlso: Actrapid, Novo Nordisk, A10AB01Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour. | Drug | type 2 diabetes |
| insulinAlso: Actrapid, Novo Nordisk, A10AB01Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour. | Drug | healthy subjects |
| dietThe subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day. | Other | healthy subjects |
| no dietThe subjects will ingest a non-restricted diet prior to the study day. | Other | healthy subjects |
Primary outcome
VLDL1 and VLDL2-triglyceride secretion rate (µmol/min)
Time frame: 7 hours
VLDL1 and VLDL2 kinetics assessed 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 9 Dec 2014.
- Derived from this study: PubMed 26781548Johansen RF, Sondergaard E, Sorensen LP, Jurik AG, Christiansen JS, Nielsen S. Basal and insulin-regulated VLDL1 and VLDL2 kinetics in men with type 2 diabetes. Diabetologia. 2016 Apr;59(4):833-43. doi: 10.1007/s00125-015-3856-5. Epub 2016 Jan 19.
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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.
Rakel F Johansen, M.D. principal investigator
University of Aarhus
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 2 Diabetes and Dyslipidemia, 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 7 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 9 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?
VLDL1 and VLDL2-triglyceride secretion rate (µmol/min) (time frame: 7 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 NCT01564550, 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 9 Dec 2014.