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Effect of Pioglitazone on TIMP-3 and TACE in Type 2 Diabetes (PIO-TACE)

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ClinicalTrials.gov Identifier: NCT01223196
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : November 13, 2014
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Franco Folli, MD, The University of Texas Health Science Center at San Antonio

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Type 2 Diabetes
Interventions Drug: Pioglitazone
Drug: Placebo
Enrollment 60
Recruitment Details Total of 60 patients were screened and 24 met the eligibility criteria and were randomized.
Pre-assignment Details 36 patients did not meet the eligibility criteria and were excluded.
Arm/Group Title Placebo Pioglitazone
Hide Arm/Group Description One arm of the study subjects will be treated with Placebo only, once a day. One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
Period Title: Overall Study
Started 13 11
Completed 9 11
Not Completed 4 0
Reason Not Completed
Lost to Follow-up             2             0
Physician Decision             1             0
Withdrawal by Subject             1             0
Arm/Group Title Placebo Pioglitazone Total
Hide Arm/Group Description One arm of the study subjects will be treated with Placebo only. One arm of the study subjects will be treated with Pioglitazone Total of all reporting groups
Overall Number of Baseline Participants 13 11 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
11
 100.0%
24
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 11 participants 24 participants
55  (7) 56.6  (9.3) 55.7  (8.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 24 participants
Female
4
  30.8%
4
  36.4%
8
  33.3%
Male
9
  69.2%
7
  63.6%
16
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 11 participants 24 participants
13 11 24
1.Primary Outcome
Title Whole Body Insulin Sensitivity During the Euglycemic Insulin Clamp
Hide Description

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)

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
M/I
Arm/Group Title Placebo Pioglitazone
Hide Arm/Group Description:
One arm of the study subjects will be treated with Placebo only.
One arm of the study subjects will be treated with Pioglitazone
Overall Number of Participants Analyzed 9 11
Mean (Standard Error)
Unit of Measure: Mg. of glucose/kg body w./mUxl ins.
M/I at baseline 3.2  (0.01) 3.01  (0.02)
M/I after 6 months of treatment 3.4  (0.02) 3.7  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pioglitazone
Comments Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups. Treatment-induced changes were examined by Wilcoxon’s rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences 20), Chicago, IL, USA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney test was used to test differences in M/I. Statistical Analysis applies to (M/I) between Pioglitazone and Placebo after 6 months.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pioglitazone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney test was used to test differences in whole body insulin sensitivity (M/I) between groups.
2.Secondary Outcome
Title Effect of Pioglitazone on TNF (Tumor Necrosis Factor) Alpha Converting Enzyme (TACE) Activity in Skeletal Muscle.
Hide Description 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.)
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
These individuals completed both the baseline and all intermediate and the end of study visits.
Arm/Group Title Placebo Pioglitazone
Hide Arm/Group Description:
One arm of the study subjects will be treated with Placebo only.
One arm of the study subjects will be treated with Pioglitazone
Overall Number of Participants Analyzed 9 11
Mean (Standard Error)
Unit of Measure: Tace Activity in F.U./mg prot
TACE Activity at baseline (F.U./mg/prot) 0.2  (0.03) 0.28  (0.04)
TACE Activity after 6 months(F.U./mg/prot) 0.15  (0.02) 0.06  (0.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pioglitazone
Comments Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups. Treatment-induced changes were examined by Wilcoxon’s rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney test was used to test differences in TACE activity in skeletal muscle between groups.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Pioglitazone
Comments Statistical analysis 2 also used 2-sided t-test similar to Statistical analysis -1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments Statistical Analysis applies toTNF (Tumor Necrosis Factor) alpha converting enzyme (TACE) activity between Pioglitazone and Placebo after 6 months.
3.Other Pre-specified Outcome
Title Percentage (%) of Haemoglobin A1C
Hide Description HbA1c (Haemoglobin A1c) is glycosylated haemoglobin, measured as a % of total Hb in red blood cells by a standard biochemical method (HPLC).
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Pioglitazone
Hide Arm/Group Description:
One arm of the study subjects will be treated with Placebo only, once a day.
One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
Overall Number of Participants Analyzed 9 11
Mean (Standard Error)
Unit of Measure: Percentage (%) of HbA1c
HbA1c - baseline 8.0  (0.5) 7.0  (0.2)
HbA1c- after 6 months 7.7  (0.5) 6.5  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Pioglitazone
Comments Mann-Whitney test was used to test differences Haemoglobin A1C between groups. Treatment-induced changes were examined by Wilcoxon’s rank test. Data were analyzed using SPSS 20 (Statistical Package for Social Sciences, Chicago, IL, USA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Mann-Whitney test was used to test differences in Heamoglobin A1c between groups.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Pioglitazone
Hide Arm/Group Description One arm of the study subjects will be treated with Placebo only. One arm of the study subjects will be treated with Pioglitazone
All-Cause Mortality
Placebo Pioglitazone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Pioglitazone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Pioglitazone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/13 (7.69%)      0/11 (0.00%)    
Blood and lymphatic system disorders     
anemia  [1]  1/13 (7.69%)  1 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
patient was on placebo, but was noted to have marked anemia while on the study and was disenrolled
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Franco Folli, MD PhD/Professor
Organization: UT Health Science Center San Antonio
Phone: 210-567-4826
EMail: FOLLI@uthscsa.edu
Layout table for additonal information
Responsible Party: Franco Folli, MD, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01223196     History of Changes
Other Study ID Numbers: HSC20080452
First Submitted: July 21, 2010
First Posted: October 18, 2010
Results First Submitted: February 19, 2013
Results First Posted: November 13, 2014
Last Update Posted: January 11, 2016