| Trial ID: | L4002 |
| Source ID: | NCT01150981
|
| Associated Drug: |
Rosiglitazone
|
| Title: |
Effect of Rosiglitazone on the Vascular Biology of Human Fat Tissue
|
| Acronym: |
RAPA
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01150981/results
|
| Conditions: |
Metabolic Syndrome|Insulin Resistance
|
| Interventions: |
DRUG: Rosiglitazone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Adipose Tissue Capillary Sprout Formation, Adipose tissue collected at 8 weeks was cut into \~1mm pieces which were embedded in individual wells of a 96 well plate containing growth factor depleted Matrigel. Wells were filled with media supplemented with endothelial growth factors, replaced every second day. Values for each patient are expressed as the difference in the average number of capillary branches (sprouts) formed by each of approximately 50 explants between day 14 and day 7. The number of branches forming on the periphery (defined as at least three cells in a branch structure) was counted by two investigators at day 7 and 14., 8 weeks | Secondary: Serum Adiponectin, Adiponectin concentrations in serum were measured in ng/ml, in both arms at baseline and at 8 weeks, i.e. 2 weeks after stopping drug or placebo treatment, 8 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Massachusetts, Worcester | Collaborators: GlaxoSmithKline
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
35
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2006-11
|
| Completion Date: |
2010-04
|
| Results First Posted: |
2012-03-26
|
| Last Update Posted: |
2012-03-26
|
| Locations: |
UMass Medical School, Worcester, Massachusetts, 01655, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01150981
|
