Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL concentrations.

Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the impact of HDL increasing drugs on HDL qualitative changes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Investigacio Sanitaria Pere Virgili
• Collaborator: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
• Treatments: Fenofibrate; Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Type 2 diabetic patients

• Age from 30 years to 70 years

• HDL not exceeding 50 mg/dl in men or 60 mg/dl in women

Exclusion Criteria:

• to be a smoker

• To be diagnosed with diabetes less than three months before

• To have triglyceride levels above 400 mg/dl

• Glycated hemoglobin higher than 9%

• Albuminuria above 300 mg/mg creatinine

• Chronic kidney disease (eFGR <30 ml/min/1.73 m2)

• Advanced retinopathy

• Neuropathy

• Cardiovascular disease in the last three months

• Chronic liver insufficiency

• Neoplastic disease or any chronic or incapacitating disease