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

Primary Purpose

Obesity, Dyslipidemia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Glucose clamp
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Alcohol misuse
  • Smoking
  • Use of prescription drugs

Sites / Locations

  • Department of Endocrinology and Internal Medicine, Aarhus University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glucose clamp

Arm Description

Outcomes

Primary Outcome Measures

VLDL-TG kinetics
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
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.

Full Information

First Posted
August 24, 2010
Last Updated
June 16, 2011
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01205750
Brief Title
Hepatic Insulin Sensitivity and Very Low Density Lipoprotein Triglyceride (VLDL-TG) Kinetics
Official Title
Basal and Insulin Mediated VLDL-triglyceride Kinetics in Obesity; Relationship With Hepatic Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Extensive description not included.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Dyslipidemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucose clamp
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Glucose clamp
Other Intervention Name(s)
Human insulin
Intervention Description
450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min
Primary Outcome Measure Information:
Title
VLDL-TG kinetics
Description
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.
Time Frame
VLDL-TG kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)
Secondary Outcome Measure Information:
Title
Hepatic insulin sensitivity
Description
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.
Time Frame
Glucose kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy BMI < 25 kg/m2 or > 30 kg/m2 Informed consent Exclusion Criteria: Alcohol misuse Smoking Use of prescription drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Søren Nielsen, DMSc
Organizational Affiliation
Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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

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