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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01205750
First received: August 24, 2010
Last updated: June 16, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Dyslipidemia
 Other: Glucose clamp

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Basal and Insulin Mediated VLDL-triglyceride Kinetics in Obesity; Relationship With Hepatic Insulin Sensitivity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • VLDL-TG kinetics [ Time Frame: VLDL-TG kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Hepatic insulin sensitivity [ Time Frame: Glucose kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes) ] [ Designated as safety issue: No ]
    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.


Enrollment: 24
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glucose clamp Other: Glucose clamp
450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min
Other Name: Human insulin

Detailed Description:

Extensive description not included.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Alcohol misuse
  • Smoking
  • Use of prescription drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01205750

Locations
Denmark
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Søren Nielsen, DMSc Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
  More Information

No publications provided

Responsible Party: Søren Nielsen, DMSc, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
ClinicalTrials.gov Identifier: NCT01205750     History of Changes
Other Study ID Numbers: 2009-0132
Study First Received: August 24, 2010
Last Updated: June 16, 2011
Health Authority: Denmark: The Ministry of the Interior and Health

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
 Lipid Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013