Clinical trial NCT01564550: The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
Official title: The Effect of Type 2 Diabetes and Dietary Regulation on VLDL1-and VLDL2-triglyceride Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Dyslipidemia
Keywords: Type 2 diabetes
Very-low-density-lipoprotein(VLDL)
VLDL1
VLDL2
hyperinsulinemia
diet
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 30
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: VLDL1 and VLDL2-triglyceride secretion rate (µmol/min)
timeFrame: 7 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Endocrinology MEA, Aarhus Hospital
Study officials:
affiliation: University of Aarhus
name: Rakel F Johansen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.