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Completed

NCT Number: NCT01205750

Hepatic Insulin Sensitivity and Very Low Density Lipoprotein Triglyceride (VLDL-TG) Kinetics

Obesity is associated with 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 dyslipidemia.

The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during acute hyperinsulinemia using VLDL-TG and glucose tracers.

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Key information

Conditions

Obesity Body Weight Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

Extensive description not included.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy
  • BMI < 25 kg/m2 or > 30 kg/m2
  • Informed consent

Exclusion criteria

  • Alcohol misuse
  • Smoking
  • Use of prescription drugs

Treatment and study plan

Glucose clamp

Other

450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min

Other names: Human insulin

Primary outcomes

  1. VLDL-TG kinetics

    Time frame: VLDL-TG kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)

    VLDL-TG secretion rates(umol/min) and clearance rates (ml/min)are determined during 30 min steady state periods postabsorptively and using acute hyperinsulinemia using primed-constant infusion of ex vivo-labelled 14C-VLDL-TG tracer and traditional tracer dilution technique.

Secondary outcomes

  1. Hepatic insulin sensitivity

    Time frame: Glucose kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)

    Hepatic glucose production (mg/min) is determined during 30 min steady state periods postabsorptively and during acute hyperinsulinemia using primed constant infusion og 3H-glucose tracer and traditional tracer dilution technique.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Basal and Insulin Mediated VLDL-triglyceride Kinetics in Obesity; Relationship With Hepatic Insulin Sensitivity

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 20, 2010
Registry last updated
Jun 17, 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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