| Trial ID: | L5130 |
| Source ID: | NCT02153879
|
| Associated Drug: |
Fenofibrate
|
| Title: |
Characterization of High Density Lipoprotein (HDL) in Type 2 Diabetes (T2D) After Fenofibrate or Niacin Treatment
|
| Acronym: |
LOWHDL
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus|Dyslipidemia
|
| Interventions: |
DRUG: Fenofibrate|DRUG: Niacin plus laropiprant
|
| Outcome Measures: |
Primary: 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: Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l), Apoprotein and antioxidant enzymes composition of HDL were also measured, Two periods of 12 weeks treatment according to crossing over design | Other: Lecithin-cholesterol acyltransferase (LCAT) and cholesteryl ester transfer protein (CETP) activity (AU - pmol/h*μl) and mass (microg/ml), LCAT and CETP mass and activities were measured;, Two periods of 12 weeks treatment according to crossing over design
|
| Sponsor/Collaborators: |
Sponsor: Institut Investigacio Sanitaria Pere Virgili | Collaborators: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
30
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2009-02
|
| Completion Date: |
2013-12
|
| Results First Posted: |
|
| Last Update Posted: |
2014-06-03
|
| Locations: |
Hospital Universitari Sant Joan, Reus, Tarragona, 43204, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT02153879
|
