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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564550
• Other study ID #: 33046
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: December 5, 2014
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Dyslipidemia
• Dyslipidemias
• Type 2 Diabetes

Intervention

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.
• 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:
• diet
The subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day.
• no diet
The subjects will ingest a non-restricted diet prior to the study day.

Locations

Country	Name	City	State
Denmark	Department of Endocrinology MEA, Aarhus Hospital	Aarhus C

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VLDL1 and VLDL2-triglyceride secretion rate (µmol/min)	VLDL1 and VLDL2 kinetics assessed over a single study day.	7 hours	No