The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism

December 5, 2014 updated by: University of Aarhus
In this study the investigators wish to compare Very Low-Density Lipoprotein (VLDL) kinetics in type 2 diabetic males and healthy males postabsorptive and during hyperinsulinemia. The kinetics is obtained using an ex-vivo VLDL1- and VLDL2-triglyceride labeling technique. The investigators hypothesis is that the investigators will find an increased VLDL1 production in type 2 diabetic males, which is not lowered by hyperinsulinemia. Also the investigators wish to investigate the influence of diet on VLDL1 and VLDL2 production in healthy males, where the investigators expect less variance in VLDL production when the subject is given an isocaloric diet.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with type 2 diabetes are more likely to suffer from dyslipidemia. Earlier research has shown that these patients have an increased VLDL production and this could be a key factor in dyslipidemia development. Especially the production of VLDL1 seems to be increased where an inhibitory response to insulin is lacking. Further investigation in VLDL1 and VLDL2 kinetics is required.

The investigators wish:

  1. To extend the method of ex vivo labeling of VLDL-triglyceride, to include separate labeling of VLDL1- and VLDL2-triglyceride for evaluation of the separate lipoprotein subtype kinetics.
  2. To investigate VLDL1- and VLDL2-triglyceride kinetics in the post absorptive state and under experimental hyperinsulinemia in twelve type 2 diabetic males compared to twelve healthy age, sex, and BMI matched males.
  3. To investigate the effect of a three day isocaloric diet compared to a non-restricted diet on the day-to-day variation in VLDL1 and VLDL2-triglyceride kinetics in healthy men. The investigators here examine six subjects on two different days who ingest a non-restricted diet and compare this group to six subjects examined on two different days, who have prior ingest a three day isocaloric diet.

Study Type

Observational

Enrollment (Actual)

30

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 C, Denmark, 8000
        • Department of Endocrinology MEA, Aarhus 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

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The type 2 diabetic men will be recruited from the endocrinology ambulatory of Aarhus University hospital. The healthy subjects will be recruited by local advertisement in the city of Aarhus and by national website advertisement.

Description

Inclusion Criteria:

  • patients with type 2 diabetes during at least six month or healthy subjects
  • male
  • BMI 25-36 kg/m2
  • age 35-65

Exclusion Criteria:

  • other diseases (hypertension and hypercholesterolemia tolerated)
  • Insulin treatment
  • alcohol abuse
  • smoking
  • medication affecting lipid metabolism apart from statins and antihypertensive drugs paused 2 weeks prior to the study day.
  • participation in studies involving radioactive isotopes or larger x-ray investigations within the last six month.
  • blood donation within three month.

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 diabetes
Drug: Insulin
Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.
Other Names:
  • Actrapid, Novo Nordisk, A10AB01
healthy subjects
Drug: insulin
Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.
Other Names:
  • Actrapid, Novo Nordisk, A10AB01
Other: diet
The subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day.
Other: no diet
The subjects will ingest a non-restricted diet prior to the study day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VLDL1 and VLDL2-triglyceride secretion rate (µmol/min)
Time Frame: 7 hours
VLDL1 and VLDL2 kinetics assessed over a single study day.
7 hours

Collaborators and Investigators

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

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Rakel F Johansen, M.D., University of Aarhus

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.

General Publications

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

November 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (ESTIMATE)

March 28, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33046

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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