Q3142321 (Q3142321): Difference between revisions
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(Created claim: summary (P836): Finding applicable preventive strategies in clinical practice is a priority to reduce the health impact of type 2 diabetes (DM2). Both lifestyle change (EV) programs that favor weight loss, and promoting a Mediterranean diet pattern (DietMed) without associated weight loss are effective in preventing DM2. However, there is so far no clinical trial that combines both strategies when studying prevention in overweight or obese population and increa...) |
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Finding applicable preventive strategies in clinical practice is a priority to reduce the health impact of type 2 diabetes (DM2). Both lifestyle change (EV) programs that favor weight loss, and promoting a Mediterranean diet pattern (DietMed) without associated weight loss are effective in preventing DM2. However, there is so far no clinical trial that combines both strategies when studying prevention in overweight or obese population and increased risk of DM2. The PREDIMED+DM study was designed to determine the effect on the incidence of DM2 of an intensive weight loss intervention based on the traditional hypocaloric DietMed pattern, physical activity and behavioral therapy vs. DietMed advice in the context of regular health care. The methodology proposed was a randomised, multicenter and parallel group clinical trial, with at least 3 years of follow-up of at least 3,600 men and women aged 55 to 75 years with overweight/obesity and metabolic syndrome, comparing the effect of both interventions described. It was proposed to compare the incidence of DM2 between the two groups after 6, 12, 24 and 36 months after the start of the intervention, evaluating possible underlying mechanisms and the safety of the intervention. Therefore, the proposal under consideration is an extension of funding to complete the PREDIMED+DM study, in which 4958 volunteers have been included having closed recruitment. The PREDIMED+DM study is part of the PREDIMED-PLUS study, a randomised clinical trial that assesses the effect of the same therapeutic strategies used in our 6 year study on primary cardiovascular prevention in patients with metabolic syndrome and overweight or obesity. Thus, the coordinated study PREDIMED+DM should be considered in the broad sense of the evaluation of cardiovascular disease prevention strategies in our country. (English) | |||||||||||||||
| Property / summary: Finding applicable preventive strategies in clinical practice is a priority to reduce the health impact of type 2 diabetes (DM2). Both lifestyle change (EV) programs that favor weight loss, and promoting a Mediterranean diet pattern (DietMed) without associated weight loss are effective in preventing DM2. However, there is so far no clinical trial that combines both strategies when studying prevention in overweight or obese population and increased risk of DM2. The PREDIMED+DM study was designed to determine the effect on the incidence of DM2 of an intensive weight loss intervention based on the traditional hypocaloric DietMed pattern, physical activity and behavioral therapy vs. DietMed advice in the context of regular health care. The methodology proposed was a randomised, multicenter and parallel group clinical trial, with at least 3 years of follow-up of at least 3,600 men and women aged 55 to 75 years with overweight/obesity and metabolic syndrome, comparing the effect of both interventions described. It was proposed to compare the incidence of DM2 between the two groups after 6, 12, 24 and 36 months after the start of the intervention, evaluating possible underlying mechanisms and the safety of the intervention. Therefore, the proposal under consideration is an extension of funding to complete the PREDIMED+DM study, in which 4958 volunteers have been included having closed recruitment. The PREDIMED+DM study is part of the PREDIMED-PLUS study, a randomised clinical trial that assesses the effect of the same therapeutic strategies used in our 6 year study on primary cardiovascular prevention in patients with metabolic syndrome and overweight or obesity. Thus, the coordinated study PREDIMED+DM should be considered in the broad sense of the evaluation of cardiovascular disease prevention strategies in our country. (English) / rank | |||||||||||||||
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| Property / summary: Finding applicable preventive strategies in clinical practice is a priority to reduce the health impact of type 2 diabetes (DM2). Both lifestyle change (EV) programs that favor weight loss, and promoting a Mediterranean diet pattern (DietMed) without associated weight loss are effective in preventing DM2. However, there is so far no clinical trial that combines both strategies when studying prevention in overweight or obese population and increased risk of DM2. The PREDIMED+DM study was designed to determine the effect on the incidence of DM2 of an intensive weight loss intervention based on the traditional hypocaloric DietMed pattern, physical activity and behavioral therapy vs. DietMed advice in the context of regular health care. The methodology proposed was a randomised, multicenter and parallel group clinical trial, with at least 3 years of follow-up of at least 3,600 men and women aged 55 to 75 years with overweight/obesity and metabolic syndrome, comparing the effect of both interventions described. It was proposed to compare the incidence of DM2 between the two groups after 6, 12, 24 and 36 months after the start of the intervention, evaluating possible underlying mechanisms and the safety of the intervention. Therefore, the proposal under consideration is an extension of funding to complete the PREDIMED+DM study, in which 4958 volunteers have been included having closed recruitment. The PREDIMED+DM study is part of the PREDIMED-PLUS study, a randomised clinical trial that assesses the effect of the same therapeutic strategies used in our 6 year study on primary cardiovascular prevention in patients with metabolic syndrome and overweight or obesity. Thus, the coordinated study PREDIMED+DM should be considered in the broad sense of the evaluation of cardiovascular disease prevention strategies in our country. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 13:39, 12 October 2021
Project Q3142321 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3142321 in Spain |
Statements
45,125.0 Euro
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90,250.0 Euro
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50.0 percent
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1 January 2018
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31 March 2021
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UNIVERSIDAD DE LAS ISLAS BALEARES
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39°34'10.49"N, 2°39'0.25"E
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07040
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Encontrar estrategias preventivas aplicables en práctica clínica es prioritario para reducir el impacto sanitario de diabetes tipo 2 (DM2). Tanto programas de cambio de estilo de vida (EV) que favorecen pérdida de peso, como promover un patrón de dieta mediterránea (DietMed) sin pérdida ponderal asociada son eficaces para prevenir DM2. Sin embargo, no existe hasta hoy ningún ensayo clínico que combine ambas estrategias al estudiar la prevención en población con sobrepeso u obesidad y riesgo aumentado de DM2. El estudio PREDIMED+DM se diseñó con el objetivo de determinar el efecto sobre la incidencia de DM2 de una intervención intensiva de pérdida de peso basada en el patrón DietMed tradicional hipocalórica, actividad física y terapia conductual vs. consejos sobre DietMed en el contexto de cuidados sanitarios habituales. La metodología propuesta fue la de ensayo clínico aleatorizado, multicéntrico y grupos paralelos, con seguimiento de al menos 3 años de al menos 3600 hombres y mujeres de 55 a 75 años de edad con sobrepeso/obesidad y síndrome metabólico, comparando el efecto de ambas intervenciones descritas. Se planteó comparar la incidencia de DM2 entre los dos grupos tras 6, 12, 24 y 36 meses de iniciada la intervención, evaluando posibles mecanismos subyacentes y la seguridad de la intervención. Por tanto, la propuesta sometida a consideración es una extensión de financiación para completar el estudio PREDIMED+DM en el que habiendo cerrado el reclutamiento se han incluido 4958 voluntarios. El estudio PREDIMED+DM se enmarca en el estudio PREDIMED-PLUS, un ensayo clínico aleatorizado que valora el efecto de las mismas estrategias terapéuticas usadas en nuestro estudio por un periodo de 6 años sobre prevención primaria cardiovascular en pacientes con síndrome metabólico y sobrepeso u obesidad. Así, el estudio coordinado PREDIMED+DM debe ser considerado en el sentido amplio de la evaluación de estrategias de prevención de enfermedad cardiovascular en nuestro país. (Spanish)
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Finding applicable preventive strategies in clinical practice is a priority to reduce the health impact of type 2 diabetes (DM2). Both lifestyle change (EV) programs that favor weight loss, and promoting a Mediterranean diet pattern (DietMed) without associated weight loss are effective in preventing DM2. However, there is so far no clinical trial that combines both strategies when studying prevention in overweight or obese population and increased risk of DM2. The PREDIMED+DM study was designed to determine the effect on the incidence of DM2 of an intensive weight loss intervention based on the traditional hypocaloric DietMed pattern, physical activity and behavioral therapy vs. DietMed advice in the context of regular health care. The methodology proposed was a randomised, multicenter and parallel group clinical trial, with at least 3 years of follow-up of at least 3,600 men and women aged 55 to 75 years with overweight/obesity and metabolic syndrome, comparing the effect of both interventions described. It was proposed to compare the incidence of DM2 between the two groups after 6, 12, 24 and 36 months after the start of the intervention, evaluating possible underlying mechanisms and the safety of the intervention. Therefore, the proposal under consideration is an extension of funding to complete the PREDIMED+DM study, in which 4958 volunteers have been included having closed recruitment. The PREDIMED+DM study is part of the PREDIMED-PLUS study, a randomised clinical trial that assesses the effect of the same therapeutic strategies used in our 6 year study on primary cardiovascular prevention in patients with metabolic syndrome and overweight or obesity. Thus, the coordinated study PREDIMED+DM should be considered in the broad sense of the evaluation of cardiovascular disease prevention strategies in our country. (English)
12 October 2021
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Palma de Mallorca
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Identifiers
PI17_01827
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