- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037647
VLDL-triglyceride Kinetics in Type 2 Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
DK
-
Aarhus, DK, Denmark, 8000
- Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Exclusion Criteria:
- Known disease except type 2 diabetes (type 2 diabetic subjects)
- Smoking
- Alcohol abuse
- Prescription medication expect oral antidiabetics (type 2 diabetic subjects)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 2 diabetic men
Men with type 2 diabetes
|
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).
|
Healthy men
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
VLDL-TG production and clearance rates
|
Secondary Outcome Measures
Outcome Measure |
---|
VLDL-TG oxidation
|
VLDL-TG subcutaneous adipose tissue storage
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Søren Nielsen, DMSc, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
Publications and helpful links
General 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.
- Sorensen 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20070028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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