- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04710186
AR, IGF-IR, IR and Peripheral Artery Disease (ANIMALPAD)
The Influence of Androgen Receptor, Insulin Like Growth Factor 1 Receptor, and Insulin Receptor in Male Patients With Peripheral Artery Disease
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Peripheral artery disease (PAD) of lower limbs is one of the most common clinical manifestation of atherosclerosis and can be considered a major cardiovascular disease with important morbidity and mortality, affecting also quality of life (QoL), thus representing an important public health concern. From a clinical point of view, PAD may be initially symptomatic with intermittent claudication (IC), and in critical limb ischemia (CLI), an advanced stage of PAD, with rest pain, and also with leg skin ulceration, a complication that may even lead to limb loss for amputation. From a pathophysiological point of view, in the presence of atherosclerosis, endothelial activation and dysfunction lead to hemodynamic alterations such as turbulent flow, abnormal shear stress, loss of potential energy, anomalies of vascular tone with functional impairment during leg exercise in early stages, with IC onset, and in advanced stages, during CLI stage, also with rest pain as a result of an important demand/perfusion mismatch. Endothelial dysfunction, and vascular tone are also regulated by sex hormones, and incidence and prevalence of PAD have usually been found to be higher in men than in women, and, more in general, males have a higher risk of developing cardiovascular disease during the reproductive period in comparison with females of the same age. This sex related difference in developing the disease was hypothesized to be related to the protective role of estrogens in female subjects, and harmful effects of androgens in male individuals. Furthermore, the androgen receptor (AR) seems to have a role in neointima formation, in influencing the size and the composition of atherosclerotic plaques, and also vascular smooth muscle cells (VSMCs) activity. Moreover, sex-specific effects on the metabolic system are well-known and associated with different risk profiles for cardiovascular disease and they have been also related to differences in sex hormones activities. In fact, the insulin and IGF-I signaling is mediated by hormone interaction with the insulin receptor (IR) and the IGF-I receptor (IGF-IR) which are members of subclass II of the tyrosine kinase receptor super-family and they, on one hand, participate to the metabolic homeostasis, and on the other hand, they have a direct role on VMMCs, and also in some stages of the atherosclerotic process..
The aim of this study is to evaluate the role of AR, IGF-IR, and IR on the arterial wall of male patients with PAD undergoing open revascularization surgery.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Catanzaro, Italia, 88100
- Reclutamiento
- University Magna Graecia of Catanzaro
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Male patients with peripheral artery disease (PAD) eligible to receive arterial reconstructive open surgery.
Exclusion Criteria:
- active malignancy
- advanced liver disease
- advanced heart disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Male patients with PAD
The cohort was built to collect information about the role of androgen receptor, insulin receptor and Insulin-like Growth Factor 1 Receptor (IGF-IR) expression in patients with peripheral artery disease referred to Vascular Surgeon Specialist.
|
Patients with peripheral artery disease (PAD) will undergo arterial reconstructive open surgery.
Samples obtained from diseased arteries of lower limbs of patients undergoing arterial reconstructive open surgery will be collected and immediately preserved at -80°.
Briefly, arterial tissues were excised, homogenized using a motor driven homogenizer and total RNA was isolated using Trizol reagent (Invitrogen, Milan, Italy), in accordance with the manufacturer's instructions.
The expression of Androgen Receptor (AR), insulin receptor (IR) and the IGF-I receptor (IGF-IR) will be quantified by real-time PCR using platform Quant Studio7 Flex Real-Time PCR System (Thermo Fisher Scientific, Milan, Italy), following the manufacturer's instructions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Expression of AR, IGF-IR, IR
Periodo de tiempo: at 1year
|
The expression of IR, IGF-IR and AR was quantified by real-time PCR using platform Quant Studio7 Flex Real-Time PCR System (Thermo Fisher Scientific, Milan, Italy), following the manufacturer's instructions
|
at 1year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Marcello Maggiolini, M.D., UNICAL - University of Calabria
Publicaciones y enlaces útiles
Publicaciones Generales
- Song P, Rudan D, Zhu Y, Fowkes FJI, Rahimi K, Fowkes FGR, Rudan I. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. Lancet Glob Health. 2019 Aug;7(8):e1020-e1030. doi: 10.1016/S2214-109X(19)30255-4.
- Ielapi N, Licastro N, Catana M, Bracale UM, Serra R. Vascular Nursing and Vascular Surgery. Ann Vasc Surg. 2020 Oct;68:522-526. doi: 10.1016/j.avsg.2020.05.038. Epub 2020 May 29.
- Orshal JM, Khalil RA. Gender, sex hormones, and vascular tone. Am J Physiol Regul Integr Comp Physiol. 2004 Feb;286(2):R233-49. doi: 10.1152/ajpregu.00338.2003.
- Chistiakov DA, Myasoedova VA, Melnichenko AA, Grechko AV, Orekhov AN. Role of androgens in cardiovascular pathology. Vasc Health Risk Manag. 2018 Oct 15;14:283-290. doi: 10.2147/VHRM.S173259. eCollection 2018.
- Baars A, Oosting A, Lohuis M, Koehorst M, El Aidy S, Hugenholtz F, Smidt H, Mischke M, Boekschoten MV, Verkade HJ, Garssen J, van der Beek EM, Knol J, de Vos P, van Bergenhenegouwen J, Fransen F. Sex differences in lipid metabolism are affected by presence of the gut microbiota. Sci Rep. 2018 Sep 7;8(1):13426. doi: 10.1038/s41598-018-31695-w.
- Beneit N, Fernandez-Garcia CE, Martin-Ventura JL, Perdomo L, Escribano O, Michel JB, Garcia-Gomez G, Fernandez S, Diaz-Castroverde S, Egido J, Gomez-Hernandez A, Benito M. Expression of insulin receptor (IR) A and B isoforms, IGF-IR, and IR/IGF-IR hybrid receptors in vascular smooth muscle cells and their role in cell migration in atherosclerosis. Cardiovasc Diabetol. 2016 Dec 1;15(1):161. doi: 10.1186/s12933-016-0477-3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ER.ALL.2018.39
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Receptor de andrógenos anormal
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminadoReceptor de trasplante de células hematopoyéticas | Receptor de trasplante de médula ósea | Receptor de trasplante de sangre de cordón umbilicalEstados Unidos
-
University of MichiganHoffmann-La RocheTerminadoReceptor de trasplante de riñón | Receptor de trasplante de corazónEstados Unidos
-
Tianjin Medical University Second HospitalReclutamientoTumor solido | Mutación del gen del receptor de FGF | Amplificación FGF | Reordenamiento de la familia de genes del receptor de FGF | Translocación del gen del receptor de FGFPorcelana
-
National Institute of Allergy and Infectious Diseases...Rho Federal Systems Division, Inc.; Clinical Trials in Organ Transplantation...TerminadoReceptor de trasplante de hígado | Donante Vivo (del Receptor de Trasplante de Hígado Respectivo)Estados Unidos
-
Istituto Scientifico Romagnolo per lo Studio e...TerminadoCáncer de mama con receptor de estrógeno positivo | Sobreexpresión del gen del receptor de andrógenos | Tumor con receptor de progesterona positivo | Cáncer de mama metastásico | Neoplasia de receptor de estrógeno negativo | Neoplasia de receptor de progesterona negativoItalia
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityDisponibleNeoplasma maligno | Receptor de trasplante de células hematopoyéticas | Neoplasia Benigna | Receptor de trasplante de médula óseaEstados Unidos
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI); Genentech, Inc.; Translational Breast Cancer Research... y otros colaboradoresTerminadoCáncer de mama en estadio IV | Receptor de estrógeno negativo | Receptor de estrógeno positivo | HER2/Neu Negativo | Receptor de progesterona negativo | Receptor de progesterona positivo | Carcinoma de mama triple negativoEstados Unidos
-
Sunshine Guojian Pharmaceutical (Shanghai) Co.,...Aún no reclutando
-
St Vincent's Hospital, SydneyTerminadoTumor solido | Sobreexpresión del gen del receptor de andrógenosAustralia
-
Yale UniversityJanssen Scientific Affairs, LLCAún no reclutandoOcupación del receptor muscarínicoEstados Unidos