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Trial record 60 of 1063 for:    Area Under Curve AND insulin

Clinical Trial of Pioglitazone for Prevention of Cardiac Allograft Vasculopathy After Heart Transplantation

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ClinicalTrials.gov Identifier: NCT01186250
Recruitment Status : Completed
First Posted : August 23, 2010
Results First Posted : August 18, 2016
Last Update Posted : August 18, 2016
Sponsor:
Information provided by (Responsible Party):
Kiran Khush, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Cardiac Allograft Vasculopathy
Interventions Drug: Pioglitazone
Drug: Placebo
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Period Title: Overall Study
Started 9 9
Completed 8 9
Not Completed 1 0
Arm/Group Title Pioglitazone Placebo Total
Hide Arm/Group Description

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Total of all reporting groups
Overall Number of Baseline Participants 9 9 18
Hide Baseline Analysis Population Description
Double-blind randomized clinical trial of pioglitazone versus placebo from 2010 to 2013 in heart transplant recipients who were 1-4 years post-transplant.Eighteen heart transplant patients aged 22 to 72 years were randomized (9 to pioglitazone, 9 to placebo)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  88.9%
8
  88.9%
16
  88.9%
>=65 years
1
  11.1%
1
  11.1%
2
  11.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 9 participants 18 participants
50.8
(23 to 72)
49.2
(22 to 72)
50.0
(22 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 9 participants 18 participants
Female
0
   0.0%
1
  11.1%
1
   5.6%
Male
9
 100.0%
8
  88.9%
17
  94.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 9 participants 18 participants
9 9 18
1.Primary Outcome
Title Insulin Levels Area Under Curve(AUC)
Hide Description Change from baseline in Insulin Levels During Oral Glucose Tolerance test at 1 year.
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Overall Number of Participants Analyzed 9 9
Mean (95% Confidence Interval)
Unit of Measure: h*pmol/L
-47.7
(-171.3 to 75.9)
10.7
(-76.8 to 98.2)
2.Secondary Outcome
Title Change in Intimal Volume
Hide Description Intimal volume is defined as external elastic membrane volume minus lumen (luminal) volume measured at the heart Catheterization and intravascular Ultrasound( IVUS)
Time Frame baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants enrolled were not all included in the intimal volume analysis because the Angiographic diagnostic evaluation needed for intimal volume measurement was clinically inappropriate for 3 in the pioglitazone arm and 5 in the Placebo arm at 12 months post transplant.
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: mm^3
12.2  (39.9) -26.8  (46.7)
3.Secondary Outcome
Title Change in Levels of Fasting Glucose at Baseline and 1 Year
Hide Description Oral Glucose Tolerance Test : blood was drawn for fasting plasma glucose and insulin levels, followed by ingestion of a solution containing 75grams of glucose. Repeat blood samples were collected for glucose and insulin levels at 30, 90, and 120 minutes after glucose ingestion. All glucose measurements were performed by the Clinical Translational Research Unit (CTRU) Stanford University.
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in each group did not complete the OGTT.
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
2.1  (19) 11  (33)
4.Secondary Outcome
Title Change From Baseline in TG/HDL Ratio at One Year
Hide Description Triglyceride ratio to High Density Lipoprotien
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
One drop out
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: ratio
-0.03  (6) -1.2  (3.3)
5.Secondary Outcome
Title Change in Maximal Intimal Thickness(MIT) by Intravascular Unltrasound(IVUS)
Hide Description The change in maximal intimal thickness (MIT) from baseline to one year was recorded for several matched sites in the same coronary artery, the cross sections, predominantly in the left anterior descending coronary artery, from baseline to one-year follow-up, were studied. The IVUS cross sections were matched by using identifiable landmarks in the images, such as bifurcations or arterial calcification, or external landmarks, such as coronary veins or pericardium. In addition, the one-year IVUS studies were obtained with an angiographic roadmap of where the initial IVUS study was performed along the length of the vessel. The IVUS system auto pullback was performed at .5 mm/s from the mid-distal portion of the study vessel, where an easily identifiable landmark was visible (i.e., branchpoint). The following items were measured for each patient: maximal intimal thickness (MIT), intimal area (IA), and vessel area.
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
number participants analyzed contained drops out due to clinical reasons
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Overall Number of Participants Analyzed 6 4
Mean (Standard Deviation)
Unit of Measure: mm
-0.01  (0.3) -0.02  (0.1)
6.Secondary Outcome
Title Change From Baseline in ADMA (Asymmetric Dimethylarginine) at One Year.
Hide Description Competitive ELISA assay in Stanford laboratory.
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
One participant in one arm did not have Baseline or one year data.
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Overall Number of Participants Analyzed 8 8
Mean (Standard Deviation)
Unit of Measure: umol/L
-0.05  (0.1) -0.02  (0.1)
7.Secondary Outcome
Title Change From Baseline in High-sensitivity C-reactive Protein (HsCRP) at One Year
Hide Description measure of low levels of C-reactive protein to identify low but persistent levels of inflammation
Time Frame Baseline and 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
participant drop put
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description:

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

Overall Number of Participants Analyzed 7 7
Mean (Standard Deviation)
Unit of Measure: mg/L
-3  (3) 2  (4)
Time Frame Adverse event reporting was started at first dose and approximatly one year later ( at final dose and testing) plus 30 days.
Adverse Event Reporting Description Assessment of adverse events was made by routine Comprehensive physical exam by MD, routine echocardiography, routine Comprehensive laboratory Chemistry metabolic panel, Complete Blood count, Lipid profile and all relevant drug level in the Transplant arena. In addition post GTT, research team called participant to follow up for any complaints.
 
Arm/Group Title Pioglitazone Placebo
Hide Arm/Group Description

Pioglitazone

Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months

Placebo

Placebo: placebo taken daily for one year

All-Cause Mortality
Pioglitazone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pioglitazone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)   0/9 (0.00%) 
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: Kiran K. Khush, MD
Organization: Stanford University
Phone: 650-721-3241
EMail: kiran@stanford.edu
Layout table for additonal information
Responsible Party: Kiran Khush, Stanford University
ClinicalTrials.gov Identifier: NCT01186250     History of Changes
Other Study ID Numbers: SU-05282010-6202
CTRU protocol 1314
IRB protocol 19373
First Submitted: August 19, 2010
First Posted: August 23, 2010
Results First Submitted: June 19, 2015
Results First Posted: August 18, 2016
Last Update Posted: August 18, 2016