Trial Outcomes & Findings for Does Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function (NCT NCT00586261)
NCT ID: NCT00586261
Last Updated: 2013-03-15
Results Overview
Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient's right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.
TERMINATED
NA
36 participants
After 6 months of treatment
2013-03-15
Participant Flow
Patients were recruited from the Mayo Clinic, Rochester, Minnesota.
Participant milestones
| Measure |
Pioglitazone
Pioglitazone 30 mg daily for 6 months
|
Placebo
Placebo 30 mg daily for 6 months
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does Thiazolidinedione Therapy Improve Endothelial Function and Preserve Renal Function
Baseline characteristics by cohort
| Measure |
Pioglitazone Arm
n=17 Participants
study the specific dose of pioglitazone 30 mg daily for 6 months
pioglitazone : pioglitazone 30 mg daily for 6 months
|
Placebo Arm
n=19 Participants
study the specific dose of placebo 30 mg daily for 6 months
placebo : placebo 30 mg daily for 6 months
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Age Continuous
|
74.2 years
STANDARD_DEVIATION 7.4 • n=99 Participants
|
72.1 years
STANDARD_DEVIATION 8.3 • n=107 Participants
|
73.1 years
STANDARD_DEVIATION 7.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=99 Participants
|
19 participants
n=107 Participants
|
36 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: After 6 months of treatmentPopulation: The study was stopped early due to low recruitment and no evidence of an effect in this analysis.
Brachial arterial reactivity was measured by ultrasound. A blood pressure cuff was placed around the right forearm. Using the ultrasound probe of the ultrasound, 2-dimensional images clearly defining the anterior and posterior intimal wall of the brachial artery were collected. Flow velocities were then measured using pulsed wave Doppler. The blood pressure cuff previously placed around the patient's right forearm was inflated to 200 mmHg. The cuff remained inflated for 5 minutes as the patient remained motionless and quiet. Prior to deflation, the patient was asked to remain still as flow velocities and 2-dimensional images were obtained immediately following cuff deflation. Then a 0.4 mg sublingual nitroglycerin tablet was given to all patients without a contraindication and all measurements were repeated.
Outcome measures
| Measure |
Pioglitazone Arm
n=17 Participants
study the specific dose of pioglitazone 30 mg daily for 6 months
pioglitazone : pioglitazone 30 mg daily for 6 months
|
Placebo Arm
n=19 Participants
study the specific dose of placebo 30 mg daily for 6 months
placebo : placebo 30 mg daily for 6 months
|
|---|---|---|
|
Change in Brachial Arterial Reactivity
|
0.8476 mm
Standard Error 1.35
|
2.6058 mm
Standard Error 1.35
|
Adverse Events
Pioglitazone
Placebo
Serious adverse events
| Measure |
Pioglitazone
n=17 participants at risk
Pioglitazone 30 mg daily for six months
|
Placebo
n=19 participants at risk
Placebo 30 mg daily for six months
|
|---|---|---|
|
Endocrine disorders
hypoglycemia
|
5.9%
1/17 • Number of events 1
|
0.00%
0/19
|
Other adverse events
| Measure |
Pioglitazone
n=17 participants at risk
Pioglitazone 30 mg daily for six months
|
Placebo
n=19 participants at risk
Placebo 30 mg daily for six months
|
|---|---|---|
|
Vascular disorders
edema
|
5.9%
1/17 • Number of events 1
|
0.00%
0/19
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place