Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers
19 de junio de 2017 actualizado por: St. Luke's-Roosevelt Hospital Center
Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers in Class II and III Obesity
The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers.
The study team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
A positive association between BMI and metabolic health risk is often presented graphically as a J-shaped curve with BMI on the x-axis and the biomarker of interest on the y-axis. However, BMI is frequently presented in the literature with a cut point of 35 on the x-axis, leading to the assumption that the steep association continues beyond a BMI of 35. This presentation does not capture the metabolically healthy individual with obesity.
In the population of men and women with class II and II obesity who the clinical team studied, it was examined that the association between BMI as a continuous variable from 35 to 69.9 and metabolic syndrome biomarkers (total-, low density, and high density cholesterol, triglycerides, systolic and diastolic blood pressure, fasting blood glucose, and glycosylated hemoglobin), the study team found no evidence for a positive correlation between BMI and TC, LDL-C, TG, and FBG. And while the study team did find positive and significant correlations between BMI and HDL-C, SBP, DBP, and HgbA1C, the effect sizes were small and arguably clinically insignificant.
The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The clinical team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.
Tipo de estudio
De observación
Inscripción (Actual)
691
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10025
- Mount Sinai St, Luke's
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
25 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
BMI 35- 69.9 Men and Women over age 25
Descripción
Inclusion Criteria:
- BMI in the range of 35 - 69.9
- Men and Women over age 25
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients with Class II and III Obesity
Patients enrolled in an outpatient weight loss program from 2010-2016.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The association between BMI from 35 - 69.9 and Total cholesterol
Periodo de tiempo: 7 years
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The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and total cholesterol reported in mg/dl.
Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and total cholesterol a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
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7 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The association between BMI from 35 - 69.9 and HDL- cholesterol
Periodo de tiempo: 7 years
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The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and HDL-cholesterol reported in mg/dl.
Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and HDL-cholesterol a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
|
7 years
|
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The association between BMI from 35 - 69.9 and LDL- cholesterol
Periodo de tiempo: 7 years
|
The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and LDL-cholesterol reported in mg/dl.
Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and LDL-cholesterol a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
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7 years
|
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The association between BMI from 35 - 69.9 and Triglycerides
Periodo de tiempo: 7 years
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The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and triglycerides reported in mg/dl.
Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and triglycerides a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
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7 years
|
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The association between BMI from 35 - 69.9 and Systolic Blood Pressure
Periodo de tiempo: 7 years
|
The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and systolic blood pressure reported in mm/Hg.
Resting blood pressure was performed by the patients' private physician at their private office and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and systolic blood pressure a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
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7 years
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The association between BMI from 35 - 69.9 and Diastolic Blood Pressure
Periodo de tiempo: 7 years
|
The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and diastolic blood pressure reported in mm/Hg.
Resting blood pressure was performed by the patients' private physician at their private office and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and diastolic blood pressure a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
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7 years
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The association between BMI from 35 - 69.9 and Fasting blood glucose
Periodo de tiempo: 7 years
|
The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and fasting blood glucose reported in mg/dl.
Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and fasting blood glucose a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
|
7 years
|
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The association between BMI from 35 - 69.9 and Hemoglobin A1C
Periodo de tiempo: 7 years
|
The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and hemoglobin A1C reported in percent (%).
Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program.
To determine the association between the BMIs and hemoglobin A1C a linear regression analysis was performed and reported graphically.
The regression equation, R2, and the p-value for the regression were presented on the graph.
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7 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Richard Weil, M.Ed, Icahn School of Medicine at Mount Sinai
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
4 de septiembre de 2012
Finalización primaria (Actual)
30 de septiembre de 2016
Finalización del estudio (Actual)
30 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2017
Primero enviado que cumplió con los criterios de control de calidad
19 de junio de 2017
Publicado por primera vez (Actual)
22 de junio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de junio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
19 de junio de 2017
Última verificación
1 de junio de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB 12-048x
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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