Hepatic Insulin Sensitivity and Very Low Density Lipoprotein Triglyceride (VLDL-TG) Kinetics

Obesity Clinical Trial

Official title:

Basal and Insulin Mediated VLDL-triglyceride Kinetics in Obesity; Relationship With Hepatic Insulin Sensitivity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205750
• Other study ID #: 2009-0132
• Status: Completed
• Phase: N/A
• First received: August 24, 2010
• Last updated: June 16, 2011
• Start date: March 2010
• Est. completion date: September 2010

Study information

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

Clinical Trial Summary

Obesity is associated with 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 dyslipidemia.

The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during acute hyperinsulinemia using VLDL-TG and glucose tracers.

Description:

Extensive description not included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy

• BMI < 25 kg/m2 or > 30 kg/m2

• Informed consent

Exclusion Criteria:

• Alcohol misuse

• Smoking

• Use of prescription drugs

Study Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Obesity

Intervention

Other:
• Glucose clamp
450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min

Locations

Country	Name	City	State
Denmark	Department of Endocrinology and Internal Medicine, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VLDL-TG kinetics	VLDL-TG secretion rates(umol/min) and clearance rates (ml/min)are determined during 30 min steady state periods postabsorptively and using acute hyperinsulinemia using primed-constant infusion of ex vivo-labelled 14C-VLDL-TG tracer and traditional tracer dilution technique.	VLDL-TG kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)	No
Secondary	Hepatic insulin sensitivity	Hepatic glucose production (mg/min) is determined during 30 min steady state periods postabsorptively and during acute hyperinsulinemia using primed constant infusion og 3H-glucose tracer and traditional tracer dilution technique.	Glucose kinetics are determined postabsorptively (250 minues) and during acute hyperinsulinemia (450 minutes)	No