Effect of Prolonged PDE-5 Inhibition on Insulin Signaling in Skeletal Muscle.
|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.
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|