- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01409993
Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
Tennessee
-
Nashville, Tennessee, Stati Uniti, 37232
- Vanderbilt University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion criteria:
Age > 18 years and BMI > 25 kg/M2 (> 23 kg/M2 among Asian Americans) Elevated fasting plasma glucose (100-125 mg/dL) IGT (2 hour plasma glucose 140-199 mg/dL) OR metabolic syndrome and/or hemoglobin A1c 5.7-6.4%
Exclusion criteria:
- Diabetes type 1 or type 2, as defined by a fasting glucose of 126 mg/dL or greater, a two hour plasma glucose of 200 mg/dL or greater, or the use of anti-diabetic medication.
- The use of nitrates or any disease that might require the use of nitrates.
- The use of any potent CYP3A4 inhibitor.
- subjects who have participated in a weight-reduction program during the last 6 month or whose weight has increased or decreased more than 2 kg over the preceding 6 months.
- Pregnancy. Women of child-bearing potential will be required to have undergone tubal ligation or to be using barrier methods of birth control.
- Breast-feeding.
- Cardiovascular disease such as myocardial infarction within 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, second or third degree heart block, mitral valve stenosis, aortic stenosis or hypertrophic cardiomyopathy.
- Treatment with anticoagulants.
- Treatment with metformin.
- History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack.
- History or presence of immunological or hematological disorders.
- Diagnosis of asthma.
- Clinically significant gastrointestinal impairment that could interfere with drug absorption.
- Impaired hepatic function (aspartate amino transaminase [AST] and/or alanine amino.
transaminase [ALT] >1.5 x upper limit of normal range)
- Impaired renal function (serum creatinine >1.5 mg/dl).
- Hematocrit <35%.
- Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult.
Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in
1 month).
- Treatment with lithium salts.
- History of alcohol or drug abuse.
- Treatment with any investigational drug in the 1 month preceding the study.
- Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study.
- Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: sildenafil Aim 1
sildenafil 25 mg p.o. tid
|
Sildenafil 25 mg by mouth three times a day for three months
Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil or placebo for 3 months.
Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
|
Comparatore placebo: placebo Aim 1
matching placebo p.o. tid
|
Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil or placebo for 3 months.
Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
Matching placebo three times a day for three months
|
Sperimentale: sildenafil Aim 2
sildenafil 25 mg p.o. tid
|
Sildenafil 25 mg by mouth three times a day for three months
Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil or placebo for 3 months.
Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
|
Comparatore placebo: placebo Aim 2
matching placebo p.o. tid
|
Matching placebo three times a day for three months
Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil or placebo for 3 months.
Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Insulin Secretion
Lasso di tempo: 2.5 hours after 3 months of therapy
|
in the group of subjects undergoing hyperglycemic clamp (Aim 1)
|
2.5 hours after 3 months of therapy
|
Index of Tissue Sensitivity to Insulin
Lasso di tempo: 2.5 hours after 3 months of therapy
|
in the group of subjects undergoing hyperglycemic clamp (Aim 1), calculated by dividing the average glucose infusion rate during the last hour of the clamp by the average plasma insulin concentration during the same interval
|
2.5 hours after 3 months of therapy
|
Glucose Infusion Rate
Lasso di tempo: 2.5 hours after 3 months of therapy
|
In the group of subjects undergoing euglycemic clamp (Aim 2)
|
2.5 hours after 3 months of therapy
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Fasting Plasma Glucose
Lasso di tempo: 3 months
|
3 months
|
|
Blood Pressure
Lasso di tempo: 3 months
|
Systolic blood pressure
|
3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Nancy J Brown, MD, Vanderbilt University
Pubblicazioni e link utili
Pubblicazioni generali
- Ramirez CE, Nian H, Yu C, Gamboa JL, Luther JM, Brown NJ, Shibao CA. Treatment with Sildenafil Improves Insulin Sensitivity in Prediabetes: A Randomized, Controlled Trial. J Clin Endocrinol Metab. 2015 Dec;100(12):4533-40. doi: 10.1210/jc.2015-3415. Epub 2015 Nov 18.
- Ramirez CE, Shuey MM, Milne GL, Gilbert K, Hui N, Yu C, Luther JM, Brown NJ. Arg287Gln variant of EPHX2 and epoxyeicosatrienoic acids are associated with insulin sensitivity in humans. Prostaglandins Other Lipid Mediat. 2014 Oct;113-115:38-44. doi: 10.1016/j.prostaglandins.2014.08.001. Epub 2014 Aug 28.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 110206
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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