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Completed

NCT Number: NCT01037647

VLDL-triglyceride Kinetics 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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital

Aarhus, DK, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Hyperinsulinemic euglycemic glucose clamp

Other

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).

Primary outcomes

  1. VLDL-TG production and clearance rates

Secondary outcomes

  1. VLDL-TG oxidation

  2. VLDL-TG subcutaneous adipose tissue storage

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • The Danish Diabetes Association
  • The Danish Medical Research Council
  • The Novo Nordic Foundation

Registry information

Official study title

VLDL-triglyceride Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia in Type 2 Diabetes

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Dec 23, 2009
Registry last updated
Nov 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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