VLDL-triglyceride Kinetics in Type 2 Diabetes

NCT ID: NCT01037647

Last Updated: 2011-11-07

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

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-12-31

Brief Summary

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

Type 2 diabetes is associated with diabetic dyslipidemia, which is a major risk factor for coronary heart disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins, and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central pathophysiological feature of the lipid and lipoprotein abnormalities in diabetic dyslipidemia.

The objective of this study was to investigate VLDL-TG kinetics and aspects of peripheral VLDL-TG metabolism, i.e. to what extent VLDL-TG associated fatty acids (FA) are oxidized or deposited in regional adipose tissue, in subjects with type 2 diabetes and healthy controls in the postabsorptive state and during acute hyperinsulinemia using ex-vivo labeled VLDL-TG tracers.

Detailed Description

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

Conditions

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

Type 2 Diabetes

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 diabetic men

Men with type 2 diabetes

Hyperinsulinemic euglycemic glucose clamp

Intervention Type OTHER

Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).

Healthy men

Healthy men

Hyperinsulinemic euglycemic glucose clamp

Intervention Type OTHER

Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).

Interventions

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

Hyperinsulinemic euglycemic glucose clamp

Hyperinsulinemic euglycemic glucose clamp, duration 5 hours, plasma glucose 5 mmol/l, insulin dosage 1,0 mU•kg FFM/min, human insulin (Actrapid; Novo Nordisk A/S).

Intervention Type OTHER

Eligibility Criteria

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

Exclusion Criteria

* Known disease except type 2 diabetes (type 2 diabetic subjects)
* Smoking
* Alcohol abuse
* Prescription medication expect oral antidiabetics (type 2 diabetic subjects)
Minimum Eligible Age

20 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.

The Danish Medical Research Council

OTHER

Sponsor Role collaborator

The Novo Nordic Foundation

OTHER

Sponsor Role collaborator

The Danish Diabetes Association

OTHER

Sponsor Role collaborator

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.

Søren Nielsen, DMSc

Role: PRINCIPAL_INVESTIGATOR

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Denmark

Locations

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

Medical department M (Endocrinology and Diabetes), Aarhus University Hospital

Aarhus, DK, 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.

Andersen IR, Sondergaard E, Sorensen LP, Nellemann B, Gormsen LC, Jensen MD, Nielsen S. Increased VLDL-TG Fatty Acid Storage in Skeletal Muscle in Men With Type 2 Diabetes. J Clin Endocrinol Metab. 2017 Mar 1;102(3):831-839. doi: 10.1210/jc.2016-2979.

Reference Type DERIVED
PMID: 27898284 (View on PubMed)

Sorensen LP, Andersen IR, Sondergaard E, Gormsen LC, Schmitz O, Christiansen JS, Nielsen S. Basal and insulin mediated VLDL-triglyceride kinetics in type 2 diabetic men. Diabetes. 2011 Jan;60(1):88-96. doi: 10.2337/db10-0564. Epub 2010 Sep 21.

Reference Type DERIVED
PMID: 20858686 (View on PubMed)

Other Identifiers

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

20070028

Identifier Type: -

Identifier Source: org_study_id