| Trial ID: | L6898 |
| Source ID: | NCT01156597
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| Associated Drug: |
Pioglitazone
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| Title: |
Effects of Pioglitazone on High-density Lipoprotein (HDL) Function in Persons With Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01156597/results
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: pioglitazone
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| Outcome Measures: |
Primary: Increased HDL-Cholesterol and Decreased Triglycerides, The primary endpoint will be increased high density lipoprotein cholesterol and decreased triglycerides measured as the difference after 12 or 24 weeks of treatment from baseline levels. The data are expressed as the percent change from the baseline value and calculated using he equation: * Change=\[100%\*(Endpoint value - Baseline Value)/Baseline Value\], 24 weeks | Secondary: HDL Apolipoprotein Levels at Study End-point, Lipoproteins will be isolated and analyzed using the gradient ultracentrifugation-high pressure liquid chromatography technique to isolate very low-density lipoprotein (VLDL), intermediate density lipoprotein (IDL), LDL, and high density lipoprotein (HDL) subfractions. Protein and lipid compositions of HDL is determined, 24 weeks|Cholesterol Efflux Capacity of HDL, The ability of serum HDL to remove cholesterol from cultured cells will be assessed as an in vitro method to evaluate a functional changes in HDL mediated by changes due to pioglitazone treatment. Cells were incubated with 2% serum from each study subject diluted in culture medium and incubations were performed for a total of 4 hours. Cholesterol efflux was calculated as the percent of cholesterol removed from the cells and appearing in the culture medium normalized to a reference serum pool as described in detail by de la Llera-Moya et al (de la Llera-Moya M, Drazul-Schrader D, Asztalos BF, Cuchel M, Rader DJ, Rothblat GH. The ability to promote efflux via ABCA1 determines the capacity of serum specimens with similar high-density lipoprotein cholesterol to remove cholesterol from macrophages. Arterioscler Thromb Vasc Biol. 2010 Apr;30(4):796-801. doi: 10.1161/ATVBAHA.109.199158. PMID: 20075420)., 24 weeks
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| Sponsor/Collaborators: |
Sponsor: University of Miami | Collaborators: Takeda Pharmaceuticals North America, Inc.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
30
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
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| Start Date: |
2008-04
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| Completion Date: |
2010-09
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| Results First Posted: |
2014-11-11
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| Last Update Posted: |
2014-11-21
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| Locations: |
Diabetes Research Institute, Miami, Florida, 33136, United States
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| URL: |
https://clinicaltrials.gov/show/NCT01156597
|
