Trial Outcomes & Findings for Study of Sildenafil Citrate on Insulin Resistance in African American (NCT NCT01334554)

NCT ID: NCT01334554

Last Updated: 2017-03-27

Results Overview

insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 46 participants
• Primary outcome timeframe: Insulin sensitivity measured at baseline and 4 weeks after the intervention
• Results posted on: 2017-03-27

Participant Flow

The recruitment started on 03/16/2011 and the first subject was screened on 03/17/2011. Participants were enrolled at Vanderbilt University Medical Center.

We screened 132 participants. Eighty six participants were excluded because of the following reasons: * 80 did not meet inclusion criteria * 5 declined to participate after the screening visit * 1 excluded because of difficult intravenous access.

Participant milestones

Measure	Sildenafil Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks	Placebo Participants received placebo three times a day for 4 weeks
Overall Study STARTED	23	23
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Sildenafil Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks	Placebo Participants received placebo three times a day for 4 weeks
Overall Study Adverse Event	4	2

Baseline Characteristics

Study of Sildenafil Citrate on Insulin Resistance in African American

Baseline characteristics by cohort

Measure	Sildenafil n=23 Participants Sildenafil 20 mg three times a day for 4 weeks	Placebo n=23 Participants Placebo three times a day for 4 weeks	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 9.5 • n=5 Participants	43 years STANDARD_DEVIATION 10.4 • n=7 Participants	42.4 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Height	164 cm STANDARD_DEVIATION 5.2 • n=5 Participants	162 cm STANDARD_DEVIATION 4.8 • n=7 Participants	163 cm STANDARD_DEVIATION 5.0 • n=5 Participants
Weight	104.5 kG STANDARD_DEVIATION 16.7 • n=5 Participants	102 kG STANDARD_DEVIATION 16.4 • n=7 Participants	103.3 kG STANDARD_DEVIATION 16.4 • n=5 Participants
Body mass index	39 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants	39 kg/m^2 STANDARD_DEVIATION 5.7 • n=7 Participants	39 kg/m^2 STANDARD_DEVIATION 5.4 • n=5 Participants
Waist circumference	112 cm STANDARD_DEVIATION 10.1 • n=5 Participants	108 cm STANDARD_DEVIATION 11.4 • n=7 Participants	110 cm STANDARD_DEVIATION 11.0 • n=5 Participants
HDL	44.0 mg/dL STANDARD_DEVIATION 9.9 • n=5 Participants	45 mg/dL STANDARD_DEVIATION 11.1 • n=7 Participants	44 mg/dL STANDARD_DEVIATION 10.4 • n=5 Participants
triglycerides	94.0 mg/dL STANDARD_DEVIATION 52.9 • n=5 Participants	85 mg/dL STANDARD_DEVIATION 48.5 • n=7 Participants	89 mg/dL STANDARD_DEVIATION 50.5 • n=5 Participants
glucose	90 mg/dL STANDARD_DEVIATION 10.6 • n=5 Participants	97 mg/dL STANDARD_DEVIATION 11.4 • n=7 Participants	93.5 mg/dL STANDARD_DEVIATION 11.4 • n=5 Participants
insulin	15 uU/ml STANDARD_DEVIATION 7.7 • n=5 Participants	14 uU/ml STANDARD_DEVIATION 9.9 • n=7 Participants	14.6 uU/ml STANDARD_DEVIATION 8.7 • n=5 Participants

PRIMARY outcome

Timeframe: Insulin sensitivity measured at baseline and 4 weeks after the intervention

insulin sensitivity as measured by frequently sampled intravenous glucose tolerance test

Outcome measures

Measure	Sildenafil n=19 Participants Sildenafil: 20 mg TID	Placebo n=21 Participants Placebo tablets, 1 tablet three times a day
Insulin Sensitivity Baseline	3.4 min-1/pmol/mlx10-5 Standard Deviation 2.53	2.7 min-1/pmol/mlx10-5 Standard Deviation 1.83
Insulin Sensitivity 4-week during intervention	3.2 min-1/pmol/mlx10-5 Standard Deviation 3.02	3.0 min-1/pmol/mlx10-5 Standard Deviation 2.12

SECONDARY outcome

Timeframe: Difference between FMD at baseline and 4 weeks

Population: We detected problems with the ultrasound images obtained to measure flow mediated dilation and therefore only data in 14 subjects in the sildenafil group and in 16 subjects in the placebo were analyzed.

Endothelial function was measured with flow mediated dilation, percent change

Outcome measures

Measure	Sildenafil n=14 percent change of brachial artery diamet Sildenafil: 20 mg TID	Placebo n=16 percent change of brachial artery diamet Placebo tablets, 1 tablet three times a day
Endothelial Function	4.7 percentage of brachial artery diameter Standard Deviation 2.9	5.3 percentage of brachial artery diameter Standard Deviation 3.1

Adverse Events

Sildenafil

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sildenafil n=23 participants at risk Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks	Placebo n=23 participants at risk Participants received placebo three times a day for 4 weeks
Nervous system disorders Headaches	52.2% 12/23 • Number of events 20 • 4 weeks	30.4% 7/23 • Number of events 10 • 4 weeks
Nervous system disorders dizziness	21.7% 5/23 • Number of events 6 • 4 weeks	4.3% 1/23 • Number of events 1 • 4 weeks
Musculoskeletal and connective tissue disorders back ache	13.0% 3/23 • Number of events 3 • 4 weeks	8.7% 2/23 • Number of events 3 • 4 weeks
Nervous system disorders lightheadedness	13.0% 3/23 • Number of events 3 • 4 weeks	0.00% 0/23 • 4 weeks
Musculoskeletal and connective tissue disorders edema	8.7% 2/23 • Number of events 5 • 4 weeks	0.00% 0/23 • 4 weeks
Ear and labyrinth disorders sinus infection	0.00% 0/23 • 4 weeks	8.7% 2/23 • Number of events 2 • 4 weeks
General disorders flushing	0.00% 0/23 • 4 weeks	8.7% 2/23 • Number of events 3 • 4 weeks

Additional Information

Cyndya A. Shibao

Vanderbilt University Medical Center

Phone: 6159364584

Email: cyndya.shibao@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER