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

This study is currently recruiting participants.
Verified November 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01564550
First received: February 22, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Dyslipidemia
Drug: Insulin
Drug: insulin
Other: diet
Other: no diet

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • VLDL1 and VLDL2-triglyceride secretion rate (µmol/min) [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    VLDL1 and VLDL2 kinetics assessed over a single study day.


Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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.

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.
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564550

Contacts
Contact: Rakel F Johansen, M.D. 45 40530612 Rakel_johansen@yahoo.com
Contact: Søren Nielsen, M.D.,PhD 45 89492016 soerniel@rm.dk

Locations
Denmark
Department of Endocrinology MEA, Aarhus Hospital Recruiting
Aarhus C, Denmark, 8000
Contact: Rakel F Johansen, M.D.    45 40530612    Rakel_johansen@yahoo.com   
Principal Investigator: Rakel F Johansen, M.D.         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Rakel F Johansen, M.D. University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01564550     History of Changes
Other Study ID Numbers: 33046
Study First Received: February 22, 2012
Last Updated: November 6, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Type 2 diabetes
Very-low-density-lipoprotein(VLDL)
VLDL1
VLDL2
hyperinsulinemia
diet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014