NCT01564550

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 9, 2014

Status Verified

November 1, 2012

Enrollment Period

2.1 years

First QC Date

February 22, 2012

Last Update Submit

December 5, 2014

Conditions

Type 2 DiabetesDyslipidemia

Keywords

Type 2 diabetesVery-low-density-lipoprotein(VLDL)VLDL1VLDL2hyperinsulinemiadiet

Outcome Measures

Primary Outcomes (1)

  • VLDL1 and VLDL2-triglyceride secretion rate (µmol/min)

    VLDL1 and VLDL2 kinetics assessed over a single study day.

    7 hours

Study Arms (2)

type 2 diabetes

Drug: Insulin

healthy subjects

Drug: insulinOther: dietOther: no diet

Interventions

insulinDRUG

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.

Also known as: Actrapid, Novo Nordisk, A10AB01
type 2 diabetes
dietOTHER

The subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day.

healthy subjects
no dietOTHER

The subjects will ingest a non-restricted diet prior to the study day.

healthy subjects

Eligibility Criteria

Age35 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology MEA, Aarhus Hospital

Aarhus C, 8000, Denmark

Location

Related Publications (1)

  • Johansen RF, Sondergaard E, Sorensen LP, Jurik AG, Christiansen JS, Nielsen S. Basal and insulin-regulated VLDL1 and VLDL2 kinetics in men with type 2 diabetes. Diabetologia. 2016 Apr;59(4):833-43. doi: 10.1007/s00125-015-3856-5. Epub 2016 Jan 19.

    PMID: 26781548DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 2DyslipidemiasHyperinsulinism

Interventions

InsulinDiet

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Rakel F Johansen, M.D.

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 28, 2012

Study Start

November 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 9, 2014

Record last verified: 2012-11

Locations

DK(1)