MedDataX Logo

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

NCT ID: NCT01564550

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Dyslipidemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Type 2 diabetes Very-low-density-lipoprotein(VLDL) VLDL1 VLDL2 hyperinsulinemia diet

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

type 2 diabetes

Insulin

Intervention Type 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.

healthy subjects

insulin

Intervention Type 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.

diet

Intervention Type OTHER

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

no diet

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

diet

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

Intervention Type OTHER

no diet

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Actrapid, Novo Nordisk, A10AB01 Actrapid, Novo Nordisk, A10AB01

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rakel F Johansen, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Endocrinology MEA, Aarhus Hospital

Aarhus C, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26781548 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

33046

Identifier Type: -

Identifier Source: org_study_id