- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02495961
Study of Chronic Degenerative Diseases
Study of Chronic Degenerative Diseases, Translational Medicine Approach
The prevalence of obesity and type 2 diabetes mellitus (DM) in children have been increasing in parallel at an alarming rate. In particular, the increasing prevalence of type 2 DM is attributable to genetic factors, clinical (waist circumference, adiposity and physical condition) and biochemical (insulin secretion and sensitivity, lipids and inflammation) risk, each of which represents an independent risk.
As has already studied and published in the investigators' group, the child population of Toluca has greater expression of cardiovascular risk factors than their counterparts in Bogota, Colombia. The metabolic characterization of the young population of Toluca and Bogota with new biomarkers such as homocysteine and leptin is an activity that aims to provide more metabolic data affecting young people.
Hypothesis:
After six months of follow-up there will be a greater relative risk in Mexican population to have identified another component of metabolic syndrome compared to the young population of Colombia.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Objective:
To compare the expression levels of cardiovascular risk markers in young people between 5 and 12 years of Toluca, Mexico and Bogota, Colombia.
Material and methods:
Type of study: prospective, descriptive, comparative, and longitudinal.
Sample Calculation:
For a cohort study and taking into account that in the investigators' previous publication in the Colombian population only 13% (sick rate in unexposed group) had an altered metabolic parameter; accepting an alpha risk of 0.05 and a beta of 0.2 on a risk bilateral contrast, 57 subjects were required in the exposed group (Mexican population) and 57 in unexposed to detect a minimum relative risk of 3 to find other alteration to metabolic syndrome after six months follow-up.
Measurements:
The International Physical Activity Questionnaire (IPAQ) will be applied to all children. Dietary history of three days and physical examination (height in cm , weight in kg and waist circumference in centimeters) and blood pressure (mmHg) data will be recorded. Blood samples will be taken to analyze glucose, cholesterol, HDL, triglycerides, homocysteine and leptin.
Statistics:
Variables will be tested for normality through the Kolmogorov-Smirnov and Shapiro-Wilk formulas. Variables related to the physiological and metabolic functions and anthropometric measurements will be reported in mean and standard deviation. The differences in the laboratorial and anthropometrical variables will be analyzed with the Student t test. A difference will be considered significant with a p value ≤ 0.05. The statistical program used is the Statistical Package for the Social Sciences (SPSS) version 19.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
State of Mexico
-
Toluca, State of Mexico, México, 50120
- Asociación Científica Latina A.C.
-
-
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:
- Primary school students of medium-low income.
Exclusion Criteria:
- Children with disabilities or a known chronic disease.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
Low risk population
Colombian children, between 6 and 12 years old, regular students of a Primary school.
|
High risk population
Mexican children, between 6 and 12 years old, regular students of a Primary school.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Metabolic syndrome component detection
Periodo de tiempo: six months
|
After six months of a basal evaluation, children will be re-examined in each component of the metabolic syndrome. Metabolic syndrome component detection will be determined by the measure of glucose (mg/dl), cholesterol (mg/dl), triglycerides (mg/dl), high-density lipoproteins (HDL), waist circumference (cm), hip circumference (cm) and blood pressure (mmHg). |
six months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hugo Mendieta Zerón, PhD., Asociación Científica Latina A.C.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 2014-01
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 Síndrome Metabólico X
-
Joint Authority for Päijät-Häme Social and Health...Tampere UniversityActivo, no reclutando
-
University of California, DavisNational Institute of Mental Health (NIMH)TerminadoPremutación de X frágilEstados Unidos
-
VegaVect, Inc.National Eye Institute (NEI)Activo, no reclutandoRetinosquisis | Ligado al XEstados Unidos
-
Central Hospital, Nancy, FranceAún no reclutandoCada intervención endoscópica mediante rayos XFrancia
-
National Eye Institute (NEI)TerminadoRetinosquisis | Ligado al XEstados Unidos
-
Alko Do Brasil Industria e Comercio LtdaDesconocidoExámenes de rayos X del tracto gastrointestinal
-
Reto Sutter, MDAún no reclutandoDiagnóstico por imagen | Tomografía, Rayos X Computarizados
-
University Hospital, BrestTerminadoMedida de la dosis de rayos XFrancia
-
GE HealthcareTerminadoEscáneres de tomografía computarizada de rayos XEstados Unidos
-
Ramsay Générale de SantéDr Béatrice DaoudDesconocidoRayos X de estaño | Parénquima pulmonarFrancia