| Trial ID: | L4280 |
| Source ID: | NCT01223196
|
| Associated Drug: |
Pioglitazone
|
| Title: |
Effect of Pioglitazone on TIMP-3 and TACE in Type 2 Diabetes
|
| Acronym: |
PIO-TACE
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01223196/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Pioglitazone|DRUG: Placebo
|
| Outcome Measures: |
Primary: Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp, Insulin sensitivity was measured by the euglycemic clamp before and 6 months after PIO (PIOGLITAZONE) or PLAC (PLACEBO) treatment. The outcome measure is Insulin sensitivity obtained from euglycemic insulin clamp and it is called M/I, where M = whole body glucose uptake during the euglycemic insulin clamp and I = circulating insulin levels during the euglycemic insulin clamp. It is expressed as Mg. of glucose/kg body weight/mU (milli Unit)x l (liter).of insulin (Ins), 6 months | Secondary: Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle., The activity of TACE is measured by detecting the release of a fluorogenic synthetic substrate of TACE and measuring in a fluorometer. It is expressed in Fluorescence Units (F.U.), 6 months | Other: Percentage (%) of Haemoglobin A1C, HbA1c (Haemoglobin A1c) is glycosylated haemoglobin, measured as a % of total Hb in red blood cells by a standard biochemical method (HPLC)., 6 months
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
60
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose:
|
| Start Date: |
2009-08
|
| Completion Date: |
2011-12
|
| Results First Posted: |
2014-11-13
|
| Last Update Posted: |
2016-01-11
|
| Locations: |
Bartter Research Unit , ALM VA Hospital, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01223196
|
