Ayuno intermitente para el tratamiento de la diabetes mellitus tipo 2
To test whether a lifestyle program featuring one of two forms of intermittent fasting (IER or TRE) can feasibly and effectively improve glycemia in patients with type 2 diabetes, and potentially induce diabetes remission.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Intermittent energy restriction (IER) and time-restricted eating (TRE) are two distinct forms of intermittent fasting which have yet to be compared for the treatment of type 2 diabetes. Investigators will test whether a comprehensive, intensive lifestyle program featuring each of these intermittent fasting approaches is feasible and effective for improving glycemic control in patients diagnosed with type 2 diabetes within the past 10 years. Both interventions will be delivered over one year in three phases: (1) a 12-week weight loss program featuring weekly group meetings, (2) a 12-week weight maintenance program featuring biweekly group meetings, and (3) a 6-month low-contact follow up period featuring monthly check-ins.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Diagnosed with type 2 diabetes in the past 10 years.
- Age 21-65 years
- BMI of 25 - 45 kg/m2
- HbA1c of 6.7-9.5%, or those with A1c of <6.7% on glucose-lowering medications
- Ability to participate in a graduated physical activity program
- Clearance from study physician.
Exclusion Criteria:
- Inability to attend health education meetings.
- Weight change of >=5% in the previous 3 months.
- Addition of new antihyperglycemic or weight-reducing medication in the previous 2 months.
- Serious medical risk such as ongoing treatment for cancer, uncontrolled hypertension, recent cardiac event, or other medical condition presenting acute risk of participation in a lifestyle change program.
- Untreated depression or anxiety, or increase in associated medications in the previous 3 months.
- Current participation in another lifestyle change intervention, such as a tobacco cessation program or physical activity program.
- Pregnancy or lactation within the previous six months
- Weight of >450 lbs
- Currently taking medications that may result in hypoglycemia during fasting and unwilling to stop prior to the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intermittent energy restriction (IER)
Intermittent fasting using a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week |
During Phase 1 (Weight Loss), participants will follow a very-low energy diet (VLED; 550-800 kcal/d) 2-3 days per week. On other days, participants do not have a specific kcal goal (non-fasting days). After Phase 1, IER participants will be instructed to follow a VLED 1-2 days per week as needed for weight maintenance. |
|
Experimental: Time-restricted eating (TRE)
Intermittent fasting using an 8-hour eating period. |
Participants will eat within an 8-hour period most days (at least 5 days per week). All foods and beverages containing calories will be restricted to this 8-hour period but calorie-free beverages (coffee, tea, diet soda, etc.) are allowed at any time. TRE participants will follow healthy eating guidelines for weight loss during Phase 1 but not follow a specific kcal prescription or restrict intake thereafter. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Retention
Periodo de tiempo: 52 weeks
|
Feasibility of IER and TRE over one year assessed by participant retention (% of participants completed). |
52 weeks
|
|
Adherence to Diet Protocols
Periodo de tiempo: Weekly from baseline to 52 weeks
|
Acceptability of IER and TRE over one year as assessed by compliance to program recommendations (% of weeks adhered) |
Weekly from baseline to 52 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
HbA1c
Periodo de tiempo: Change from baseline to 24 weeks
|
Change in glycemic control assessed via HbA1c (%) |
Change from baseline to 24 weeks
|
|
Postprandial Glucose
Periodo de tiempo: Change from baseline to 24 weeks
|
Estimate the effects for both IER and TRE on fasting and mean glucose during a 3 hr mixed meal tolerance test. |
Change from baseline to 24 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STUDY00149127
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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.
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