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

NCT02153879 | Completed Phase 4

• 1 other identifier: IISPV-HUSJR-LOWHDL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus; Dyslipidemia

Keywords

HDL; Niacin; Fenofibrate; Diabetes; Metabolomics

Outcome Measures

Primary Outcomes (1)

• HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L

  HDL particles were studied by NMR in T2D patients after treatment with fenofibrate or Niacin

  Two periods of 12 weeks treatment according to crossing over design

Secondary Outcomes (1)

• Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l)

  Two periods of 12 weeks treatment according to crossing over design

Other Outcomes (1)

• Lecithin-cholesterol acyltransferase (LCAT) and cholesteryl ester transfer protein (CETP) activity (AU - pmol/h*μl) and mass (microg/ml)

  Two periods of 12 weeks treatment according to crossing over design

Study Arms (2)

Fenofibrate

EXPERIMENTAL

Fenofibrate 145 mg/day for 12 weeks

Drug: Fenofibrate

Niacin plus Laropiprant

EXPERIMENTAL

Niacin 2g/day plus Laropiprant for 12 weeks

Drug: Niacin plus laropiprant

Interventions

Fenofibrate DRUG

fenofibrate 145/day for 12 weeks

Also known as: Secalip

Fenofibrate

Niacin plus laropiprant DRUG

Niacin 2 g/day plus Laropiprant for 12 weeks

Also known as: Tredaptive

Niacin plus Laropiprant

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Investigacio Sanitaria Pere Virgili: lead
• Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders: collaborator

Study Sites (1)

Hospital Universitari Sant Joan

Reus, Tarragona, 43204, Spain

Location

Related Links

• Institut Investigacio Sanitaria Pere Virgili- Pere Virgili Health Research institute

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Dyslipidemias; Diabetes Mellitus

Interventions

Fenofibrate; Niacin; MK-0524

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Luis Masana, Professor

  Institut Investigacio Sanitaria Pere Virgili

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2014
• First Posted: June 3, 2014
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

ES (1)