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VLDL-triglyceride Kinetics in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborators:
The Danish Medical Research Council
The Novo Nordic Foundation
The Danish Diabetes Association
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01037647
First received: December 21, 2009
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes
 Other: Hyperinsulinemic euglycemic glucose clamp

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: VLDL-triglyceride Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia in Type 2 Diabetes

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • VLDL-TG production and clearance rates [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VLDL-TG oxidation [ Designated as safety issue: No ]
  • VLDL-TG subcutaneous adipose tissue storage [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples Subcutaneous adipose tissue biopsies Muscle biopsies


Enrollment: 22
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 2 diabetic men
Men with type 2 diabetes
 Other: Hyperinsulinemic euglycemic glucose clamp
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
Healthy men
 Other: Hyperinsulinemic euglycemic glucose clamp
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).

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

11 men with type diabetes and 11 healthy men, matched for age and BMI.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037647

Locations
Denmark
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital
Aarhus, DK, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
The Danish Medical Research Council
The Novo Nordic Foundation
The Danish Diabetes Association
Investigators
Principal Investigator: Søren Nielsen, DMSc Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01037647     History of Changes
Other Study ID Numbers: 20070028
Study First Received: December 21, 2009
Last Updated: November 4, 2011
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by University of Aarhus:
Type 2 diabetes
Diabetic dyslipidemia
VLDL-TG kinetics
VLDL-TG metabolism

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013