| Trial ID: | L3935 |
| Source ID: | NCT00402012
|
| Associated Drug: |
Pioglitazone
|
| Title: |
"TAKE TIME" Pioglitazone Reverses Defects in Mitochondrial Biogenesis in Patients With T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Pioglitazone
|
| Outcome Measures: |
Primary: Change in skeletal muscle mitochondrial number (electron microscopy + qPCR of mtDNA) and mitochondrial gene expression in T2DM patients treated with pioglitazone (vs. placebo), baseline and after intervention | Secondary: insulin sensitivity for insulin suppression of free fatty acid and glucose disposal, baseline and after intervention|electron transport chain activity; mitochondrial content by MRS (ATP max), baseline and after intervention|intra hepatic and intra myocellular lipid by MRS; mitochondrial content by MRS (ATP max) post weight loss period, baseline ,after treatment and after weight loss
|
| Sponsor/Collaborators: |
Sponsor: Pennington Biomedical Research Center | Collaborators: Takeda Pharmaceuticals North America, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2006-11
|
| Completion Date: |
2007-12
|
| Results First Posted: |
|
| Last Update Posted: |
2015-12-18
|
| Locations: |
Pennington Biomedical Research Center, Baton Rouge, Louisiana, 70808, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00402012
|
