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El ensayo clínico NCT03336411 para Pre-diabetes, Sobrepeso y obesidad está completado. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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A Personalized Diet Study to Reduce Glycemic Exposure 269 Aleatorizado Dietético Personalizado
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT03336411 fue un estudio intervencionista para Pre-diabetes, Sobrepeso y obesidad. Su estado actual es: completado. El estudio se inició el 12 de diciembre de 2017, con el objetivo de reclutar a 269 participantes. Dirigido por NYU Langone Health, la fecha de finalización prevista fue el 27 de octubre de 2021. Los datos se actualizaron por última vez en ClinicalTrials.gov el 10 de marzo de 2022.
Resumen
The aim of this 2-phase, randomized clinical trial will be to examine the effects of two behavioral weight loss interventions on weight loss. This study will be conducted in 200 overweight or obese prediabetic individuals recruited from community-based settings.. Phase 1 will include 6-months of active intervention. Phase 2 will consist of 6-months of maintenance and observation. Measurements will occur at screening,...Mostrar más
Título oficial
Personalized Technology-Supported Counseling to Reduce Glycemic Response in Dietary Weight Loss: The Personal Diet Study
Condiciones médicas
Pre-diabetesSobrepeso y obesidadPublicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:Otros ID del estudio
- 17-00741
Número del NCT
Inicio del estudio (real)
2017-12-12
Última actualización
2022-03-10
Fecha de finalización (estimada)
2021-10-27
Inscripción (prevista)
269
Tipo de estudio
Intervencionista
FASE
N/A
Estado general
Completado
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Doble ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
Comparador activomHealth | Personalized mHealth Behavioral weight loss intervention with personalized dietary recommendations based on machine learning algorithm that integrates gut microbiota, dietary intake, physical activity and various blood parameters to predict postprandial glycemic response. |
ExperimentalPersonalized mHealth | Salud móvil Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet. |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Body weight, percent change | the primary outcome will be relative weight change as a percentage of body weight at baseline and 6-months using calibrated scale. | 6 months |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
Body Composition | the secondary outcome will be absolute and relative changes in fat and lean body mass based on bioelectrical impedance analysis (BIA) from baseline to 6-months, 6-months to 12-months and baseline to 12-months | 6 & 12 months |
Metabolic Adaptation | the secondary outcome will be the change in resting metabolic rate overall, and in relation to body weight and lean body mass from baseline to 6-months, 6- to 12-months, and baseline to 12-months. Resting metabolic rate will be estimated using indirect calorimetry with the participant in a fasting state (12 hours) | 6 & 12 months |
Weight regain | 12 months |
Criterios de elegibilidad
Criterios de edad
Adulto, Adulto mayor
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí
- Healthy overweight or obese prediabetic (HbA1c <8.0%)
- BMI ≥27 kg/m2
- Oral medications with metformin, sulfonylureas, DPP4 inhibitors
- Posses smartphone or use study loaner smartphone
- unable or unwilling to provide informed consent
- unable to participate meaningfully in an intervention that involves self-monitoring using software available in English (e.g., due to uncorrected sight impairment, illiterate, non-English-speaking, dementia)
- unwilling to accept randomization assignment
- women who pregnant, or plan to become pregnant in the next 13 months, or who become pregnant during the study
- institutionalized (e.g., in a nursing home or personal care facility, or those who are incarcerated and have limited control over diet)
- unwilling to delay bariatric surgery for the next 12 months
- diagnosed with heart disease, kidney disease, or retinopathy, (to rule-out those with long-standing T2D)
- chronically active inflammatory or neoplastic disease in the past 3 years
- diagnosed with a chronic gastrointestinal disorder (e.g. inflammatory bowel disease or celiac disease)
- diagnosed with active infection requiring antibiotics in the last 3 months or who develop an active infection requiring antibiotics during the study
- taking medications containing acetaminophen and are unwilling or unable to discontinue its use during the study (acetaminophen affects the accuracy of the continuous glucose monitoring \[CGM\] device)
- taking chronic immunosuppressive medications or used them in the 3 months prior to participation, or during the study
- managing glycemia with insulin, GLP-I agonists (exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide), insulin secretagogues (Glimepiride, Glipizide, Glyburide, Repaglinide, Nateglinide), or SGLT2 inhibitors (canagliflozin, dapagliflozin, empagliflozin, empagliflozin/metformin, dapagliflozin/metformin)
- prescribed medications expected to result in weight loss such as Orlistat, Naltrexone, Bupropion, Lorcaserin, Phentermine, Topiramate, or Liraglutide, and who are unwilling to delay treatment with these medications for the next 12 months
- +/- 5% weight change within last month at screening
- a eGFR <60 mL/min/1.73m2
- younger than 18 or older than 80 years old.
NYU Langone Health- American Heart Association
- Weizmann Institute of Science
No hay datos de contacto.
1 Centros del estudio en 1 países
New York
New York University School of Medicine, New York, New York, 10016, United States