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

June 16, 2011 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Extensive description not included.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Alcohol misuse
  • Smoking
  • Use of prescription drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucose clamp
Other: Glucose clamp
450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min
Other Names:
  • Human insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
VLDL-TG kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Glucose kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Søren Nielsen, DMSc, Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 24, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimate)

September 20, 2010

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0132

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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