VLDL-triglyceride Kinetics in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

VLDL-triglyceride Kinetics and -Metabolism in the Post Absorptive State and During Hyperinsulinemia in Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037647
• Other study ID #: 20070028
• Status: Completed
• Phase: N/A
• First received: December 21, 2009
• Last updated: November 4, 2011
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: November 2011
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

• Known disease except type 2 diabetes (type 2 diabetic subjects)

• Smoking

• Alcohol abuse

• Prescription medication expect oral antidiabetics (type 2 diabetic subjects)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Denmark	Medical department M (Endocrinology and Diabetes), Aarhus University Hospital	Aarhus	DK

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	The Danish Diabetes Association, The Danish Medical Research Council, The Novo Nordic Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VLDL-TG production and clearance rates			No
Secondary	VLDL-TG oxidation			No
Secondary	VLDL-TG subcutaneous adipose tissue storage			No