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- Ensaio Clínico NCT01409993
Renin-Angiotensin and Fibrinolysis in Humans: Effect of Long-Term PDE5 Inhibition on Glucose Homeostasis
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37232
- Vanderbilt University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: 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.
|
Comparador de 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
|
Experimental: 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.
|
Comparador de 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Insulin Secretion
Prazo: 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
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Fasting Plasma Glucose
Prazo: 3 months
|
3 months
|
|
Blood Pressure
Prazo: 3 months
|
Systolic blood pressure
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nancy J Brown, MD, Vanderbilt University
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 110206
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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