Skip to main content
OpenTrials
Completed

NCT Number: NCT01564550

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of Endocrinology MEA, Aarhus Hospital

Aarhus C, 8000, Denmark

About this study

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:

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug

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

Diet

Other

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

No diet

Other

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

Primary outcomes

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

    Time frame: 7 hours

    VLDL1 and VLDL2 kinetics assessed over a single study day.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 28, 2012
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.