VLDL-triglyceride Kinetics in Type 2 Diabetes

NCT01037647 | Completed

• 1 other identifier: 20070028
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Diabetic dyslipidemia; VLDL-TG kinetics; VLDL-TG metabolism

Outcome Measures

Primary Outcomes (1)

• VLDL-TG production and clearance rates

Secondary Outcomes (2)

• VLDL-TG oxidation

• VLDL-TG subcutaneous adipose tissue storage

Study Arms (2)

Type 2 diabetic men

Men with type 2 diabetes

Other: Hyperinsulinemic euglycemic glucose clamp

Healthy men

Healthy men

Other: Hyperinsulinemic euglycemic glucose clamp

Interventions

Hyperinsulinemic euglycemic glucose clamp 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; Type 2 diabetic men

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

11 men with type diabetes and 11 healthy men, matched for age and BMI.

You may not qualify if:

• Known disease except type 2 diabetes (type 2 diabetic subjects)
• Smoking
• Alcohol abuse
• Prescription medication expect oral antidiabetics (type 2 diabetic subjects)

Sponsors & Collaborators

• University of Aarhus: lead
• The Danish Medical Research Council: collaborator
• The Novo Nordic Foundation: collaborator
• The Danish Diabetes Association: collaborator

Study Sites (1)

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

Aarhus, DK, 8000, Denmark

Location

Related Publications (2)

• 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.

  PMID: 27898284 DERIVED

• 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.

  PMID: 20858686 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Subcutaneous adipose tissue biopsies Muscle biopsies

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Søren Nielsen, DMSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2009
• First Posted: December 23, 2009
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 7, 2011

Record last verified: 2011-11

Locations

DK (1)