Type 2 DiabetesNCT01037647
VLDL-triglyceride Kinetics in Type 2 Diabetes
An observational study of Type 2 Diabetes, run by University of Aarhus at 1 site in Denmark.
Trial summary
Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. 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
- Type 2 Diabetes
- What is being tested?
- Hyperinsulinemic euglycemic glucose clamp
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- May 2008to Dec 2008
- 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: 11 men with type diabetes and 11 healthy men, matched for age and BMI.
Who may be able to join
None listed.
Who cannot join
- Known disease except type 2 diabetes (type 2 diabetic subjects)
- Smoking
- Alcohol abuse
- Prescription medication expect oral antidiabetics (type 2 diabetic subjects)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, DK, 8000
About this study
Official title: VLDL-triglyceride Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia in Type 2 Diabetes
Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in diabetic dyslipidemia.
The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG tracers.
- Conditions
- Type 2 Diabetes
- Being tested
- Hyperinsulinemic euglycemic glucose clamp
- Keywords
- Type 2 diabetes, Diabetic dyslipidemia, VLDL-TG kinetics, VLDL-TG metabolism
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperinsulinemic euglycemic glucose clampOther
Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetic men | Men with type 2 diabetes Receives: Other: Hyperinsulinemic euglycemic glucose clamp | |
| Healthy men | Healthy men Receives: Other: Hyperinsulinemic euglycemic glucose clamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
VLDL-TG production and clearance rates
Secondary outcomes (2)
VLDL-TG oxidation
VLDL-TG subcutaneous adipose tissue storage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2008
- Study completionDec 2008
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 Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council, The Novo Nordic Foundation, The Danish Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Søren Nielsen, DMSc, Principal investigator, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037647
- Sponsor's protocol ID
- 20070028
- Status last verified
- Nov 2011
- First submitted
- 21 Dec 2009
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersen IR, Sondergaard E, Sorensen LP, Nellemann B, Gormsen LC, Jensen MD, Nielsen S. Increased VLDL-TG Fatty Acid Storage in Skeletal Muscle in Men With Type 2 Diabetes. J Clin Endocrinol Metab. 2017 Mar 1;102(3):831-839. doi: 10.1210/jc.2016-2979.
PubMed 27898284Sorensen LP, Andersen IR, Sondergaard E, Gormsen LC, Schmitz O, Christiansen JS, Nielsen S. Basal and insulin mediated VLDL-triglyceride kinetics in type 2 diabetic men. Diabetes. 2011 Jan;60(1):88-96. doi: 10.2337/db10-0564. Epub 2010 Sep 21.
PubMed 20858686
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 Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01037647
- Acronym / sponsor ID
- 20070028
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Diabetic dyslipidemia, VLDL-TG kinetics, VLDL-TG metabolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council, The Novo Nordic Foundation, The Danish Diabetes Association
- Study start
- May 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Dec 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.
Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in diabetic dyslipidemia.
The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG tracers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetic men | – | Other: Hyperinsulinemic euglycemic glucose clampMen with type 2 diabetes |
| Healthy men | – | Other: Hyperinsulinemic euglycemic glucose clampHealthy men |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 11 men with type diabetes and 11 healthy men, matched for age and BMI.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Known disease except type 2 diabetes (type 2 diabetic subjects)
- Smoking
- Alcohol abuse
- Prescription medication expect oral antidiabetics (type 2 diabetic subjects)
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 |
|---|---|---|
| Hyperinsulinemic euglycemic glucose clampHyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S). | Other | Healthy men, Type 2 diabetic men |
Primary outcome
VLDL-TG production and clearance rates
2 secondary outcomes
VLDL-TG oxidation
VLDL-TG subcutaneous adipose tissue storage
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.
- Derived from this study: PubMed 27898284Andersen IR, Sondergaard E, Sorensen LP, Nellemann B, Gormsen LC, Jensen MD, Nielsen S. Increased VLDL-TG Fatty Acid Storage in Skeletal Muscle in Men With Type 2 Diabetes. J Clin Endocrinol Metab. 2017 Mar 1;102(3):831-839. doi: 10.1210/jc.2016-2979.
- Derived from this study: PubMed 20858686Sorensen LP, Andersen IR, Sondergaard E, Gormsen LC, Schmitz O, Christiansen JS, Nielsen S. Basal and insulin mediated VLDL-triglyceride kinetics in type 2 diabetic men. Diabetes. 2011 Jan;60(1):88-96. doi: 10.2337/db10-0564. Epub 2010 Sep 21.
Related trials for Type 2 Diabetes
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
Søren Nielsen, DMSc principal investigator
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
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, 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 0 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-TG production and clearance rates. 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 NCT01037647, 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 7 Nov 2011.