Trial Outcomes & Findings for Effect of Prolonged PDE-5 Inhibition on Insulin Signaling in Skeletal Muscle. (NCT NCT02129725)
NCT ID: NCT02129725
Last Updated: 2017-04-19
Results Overview
measured using Western blot for pAkt and for total Akt from muscle biopsies obtained at the end of the baseline hyperinsulinemic clamp and the three-month hyperglycemic clamp. The ratio of pAkt to Akt expression was calculated at each time point and the change in ratio from 0 to 3 months is presented.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
3 months
Results posted on
2017-04-19
Participant Flow
Subjects consented to give muscle biopsy
Participant milestones
| Measure |
Sildenafil
In the parent study, subjects are randomized to sildenafil 25 mg tid.
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling.
|
Placebo
In the parent study, subjects are randomized to matching placebo
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Prolonged PDE-5 Inhibition on Insulin Signaling in Skeletal Muscle.
Baseline characteristics by cohort
| Measure |
Sildenafil
n=8 Participants
Subjects consented for the biopsy substudy and randomized
|
Placebo
n=7 Participants
Subjects consented for the biopsy substudy and randomized
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
47.3 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
47.4 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
7 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Body mass index
|
31.5 mg/kg2
STANDARD_DEVIATION 4.1 • n=5 Participants
|
34.5 mg/kg2
STANDARD_DEVIATION 5.0 • n=7 Participants
|
32.9 mg/kg2
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Fasting glucose
|
97.2 mg/dL
STANDARD_DEVIATION 10.3 • n=5 Participants
|
91.4 mg/dL
STANDARD_DEVIATION 13.4 • n=7 Participants
|
94.5 mg/dL
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Two-hour glucose
|
122.6 mg/dL
STANDARD_DEVIATION 45.4 • n=5 Participants
|
134.3 mg/dL
STANDARD_DEVIATION 37.9 • n=7 Participants
|
128.0 mg/dL
STANDARD_DEVIATION 41.0 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsmeasured using Western blot for pAkt and for total Akt from muscle biopsies obtained at the end of the baseline hyperinsulinemic clamp and the three-month hyperglycemic clamp. The ratio of pAkt to Akt expression was calculated at each time point and the change in ratio from 0 to 3 months is presented.
Outcome measures
| Measure |
Sildenafil
n=6 Participants
In the parent study, subjects are randomized to sildenafil 25 mg tid.
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling.
|
Placebo
n=4 Participants
In the parent study, subjects are randomized to matching placebo
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling.
|
|---|---|---|
|
Insulin-stimulated AKT Phosphorylation
|
0.065 change in ratio
Standard Deviation 0.160
|
-0.457 change in ratio
Standard Deviation 0.710
|
Adverse Events
Sildenafil
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sildenafil
n=8 participants at risk
In the parent study, subjects are randomized to sildenafil 25 mg tid.
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling.
|
Placebo
n=7 participants at risk
In the parent study, subjects are randomized to matching placebo
muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
pain at biopsy site
|
12.5%
1/8 • Number of events 1 • 6 months
|
14.3%
1/7 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
bleeding at biopsy site
|
0.00%
0/8 • 6 months
|
14.3%
1/7 • Number of events 1 • 6 months
|
|
Nervous system disorders
headache
|
25.0%
2/8 • Number of events 2 • 6 months
|
0.00%
0/7 • 6 months
|
|
Renal and urinary disorders
low potassium
|
12.5%
1/8 • Number of events 1 • 6 months
|
0.00%
0/7 • 6 months
|
|
Musculoskeletal and connective tissue disorders
joint or muscle aches
|
12.5%
1/8 • Number of events 1 • 6 months
|
14.3%
1/7 • Number of events 1 • 6 months
|
|
Cardiac disorders
vasovagal episode
|
0.00%
0/8 • 6 months
|
14.3%
1/7 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
flushing
|
12.5%
1/8 • Number of events 1 • 6 months
|
0.00%
0/7 • 6 months
|
|
Vascular disorders
hypertension
|
12.5%
1/8 • Number of events 1 • 6 months
|
0.00%
0/7 • 6 months
|
|
Blood and lymphatic system disorders
anemia
|
12.5%
1/8 • Number of events 1 • 6 months
|
0.00%
0/7 • 6 months
|
|
Cardiac disorders
palpitations
|
12.5%
1/8 • Number of events 1 • 6 months
|
0.00%
0/7 • 6 months
|
Additional Information
Nancy J. Brown, M.D.
Vanderbilt University Medical Center
Phone: 615-343-8701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place