Effect of Prolonged PDE-5 Inhibition on Insulin Signaling in Skeletal Muscle.
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|ClinicalTrials.gov Identifier: NCT02129725|
Recruitment Status : Completed
First Posted : May 2, 2014
Results First Posted : April 19, 2017
Last Update Posted : April 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Drug: Sildenafil citrate Drug: Placebo Oral Capsule||Phase 4|
Participants enrolled in the study titled " Renin-angiotensin and fibrinolysis interaction in humans: effect of long-term PDE5 inhibition on glucose Homeostasis, (Specific aim 2)" will be offered the opportunity to participate in this sub-study.
We will obtain skeletal muscle biopsies from 16 subjects who are enrolled in specific aim 2. Eight subjects will be in the sildenafil group and 8 subjects will be in the placebo group.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Renin- Angiotensin and Fibrinolysis Interaction in Humans: Effect of Long-term PDE-5 Inhibition on Glucose Homeostasis. Sub-study|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||December 2016|
Experimental: sildenafil citrate
In the parent study, subjects are randomized to sildenafil 25 mg tid.
Drug: Sildenafil citrate
Sildenafil citrate 25 mg, 1 capsule three times a day for 3 months
Other Name: Viagra
Placebo Comparator: placebo oral capsule
In the parent study, subjects are randomized to matching placebo
Drug: Placebo Oral Capsule
placebo capsules, 1 capsule po three times a day for 3 months
Other Name: placebo comparator
- Insulin-stimulated AKT Phosphorylation [ Time Frame: 3 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129725
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-6602|
|Principal Investigator:||Nancy J Brown, MD||Vanderbilt University Medical Center|