VLDL-triglyceride Kinetics in Type 2 Diabetes

November 4, 2011 updated by: University of Aarhus

VLDL-triglyceride Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

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

    • DK
      • Aarhus, DK, Denmark, 8000
        • Medical Department M (Endocrinology and Diabetes), 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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

11 men with type diabetes and 11 healthy men, matched for age and BMI.

Description

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)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 2 diabetic men
Men with type 2 diabetes
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).
Healthy men
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
VLDL-TG production and clearance rates

Secondary Outcome Measures

Outcome Measure
VLDL-TG oxidation
VLDL-TG subcutaneous adipose tissue storage

Collaborators and Investigators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

May 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 4, 2011

Last Verified

November 1, 2011

More Information

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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