- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04062773
Time-Restricted Feeding on Glucose Homeostasis and Quality of Life
A Pilot Study to Evaluate the Effect of Time-Restricted Feeding on Blood Glucose, Insulin Sensitivity and Quality of Life
Background: Time-restricted feeding can improve insulin sensitivity, and increase fat oxidation in people with prediabetes independent of weight loss. It may also help people to lose weight. However, it has not been tested in people with type 2 diabetes.
Plan of investigation: Participants meeting the eligibility criteria will be randomized to the TRF arm or the continuous eating arm. Both arms with be given a prescribed dietary plan to help them lose 5% of body weight. In the TRF they will permitted to eat between midday and 6pm. In the continuous eating arm they will be allowed to eat between 8am and 11pm. Participants will attend the nutrition clinic every two weeks to be weighed and be given personalized support to help them follow their assigned diet. Prior to starting the diets outcome measures will be taken: Glycaemia will be measured by a glucose tolerance test, and 7-day continuous glucose monitoring. HbA1c will be taken from fasting blood sample. In addition, the fasting sample will be taken for measurement of insulin, lipid profile and inflammatory markers. We will also use questionnaires to assess quality of life, a 3-day food diary to assess compliance to diet especially meal timings. Capillary ketones will also be used to assess whether compliance to the assigned fasting period. Outcome measures will also be taken during 7 days of the second month, and then the final seven days of the last month on the diet. The primary outcome is HbA1c.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Experimental Design
12-week parallel randomised control trial
Recruitment
We will recruit via advertisements outside Dasman using social media and local ads in addition to screening of Dasman Registry for any potential participants. Opportunistic recruitment will also occur by DDI dietitians. Following telephone screening to ensure the potential participant meets initial screening criteria we will carry out a medical screening to ensure the person can take part.
Environment All screening, dietary counselling visits, and placement of the CGM will take place at the Dasman Diabetes Institute (DDI). The institute has extensive space for interventional studies, including screening rooms, body composition assessment and clinical rooms for placement of the CGM monitor.
STUDY INTERVENTIONS
For both groups all participants will be guided towards a 5% weight loss based on individualised energy requirements. The difference will be the hours during which the participants consume their required calories.
- Time restricted feeding group: Will consume their calories between 12pm and 6pm.
- Continuous energy restriction group: Will consume their calories between 8am and 11pm.
Participants will be guided towards their weight loss during one-to-one visits at baseline and every 2 weeks for 12 weeks.
Procedures
- At baseline and follow-up all participants will undergo an oral glucose tolerance test.
- A blood sample will also be taken for HbA1c, lipid profile, fasting insulin, inflammatory factors and a sample for Biobank. The biobank sample will be stored to enable us, with other researchers at DDI to understand the heterogeneity of type 2 diabetes; whether certain people respond to dietary interventions based on their genetic, epigenetic or metabolomic background; and ultimately will help guide clinical care.
- Participants will wear Flash Glucose monitoring or other continuous glucose monitoring device to measure their 24-hour blood glucose concentrations during the seven days preceding the start of the dietary intervention, seven days of the second month, and the final seven days of the third month.
- Participants will also measure their capillary ketones during the first three days of the first month, three days of the second month, and final three days of the third month.
- Medication changes: prandial medications (insulin or sulphonylurea) will be altered to the timing of meal intake. Any reduction in medication due to changes in glucose will be carried out by the patient's doctor.
- A quality of life questionnaire: PAID.
- A 3 day food diary with meal times to check compliance.
Statistical Methods
This is a pilot study. We will recruit 25 people per group. This is based on recommendations for sample sizes for feasibility and pilot studies.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nicola Guess, PhD
- Número de teléfono: 2033 +965 2224 2999
- Correo electrónico: Nicola.Guess@dasmaninstitute.org
Ubicaciones de estudio
-
-
-
Kuwait City, Kuwait, 15462
- Reclutamiento
- Dasman Diabetes Institute
-
Contacto:
- Nicola Guess, PhD
- Número de teléfono: 2033 +965 2224 2999
- Correo electrónico: Nicola.Guess@dasmaninstitute.org
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must agree to follow time restricted feeding protocol if randomized to the TRF arm.
- Age 21-65 years
- T2DM with any diabetes medication
- BMI of 25-45 kg/m2
- Wake up at a regular time between 5-8 am
- Able to provide informed consent.
Exclusion Criteria:
- Weight loss of more than 5 kg within the past 6 months
- HbA1c of <6·5% and >12%
- Serious current or recent illness including cancer or severe or unstable heart failure.
- Participation in another clinical research trial.
- Current treatment with anti-obesity drugs.
- Substance abuse
- Learning difficulties
- Presence of an eating disorder
- Purging behaviour
- Pregnancy or consideration of pregnancy
- Hospital admission for depression or use of antipsychotic drugs.
- Regularly eat within a <9-hour period each day
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: TRF
Eating restricted to between midday and 6pm.
|
time restricted feeding group
|
Comparador de placebos: Normal timing of food intake.
Eating between 8am and 11pm.
|
no time restricted feeding
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HbA1c
Periodo de tiempo: 12 weeks
|
Change in HbA1c between the intervention and control arms.
|
12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Body weight
Periodo de tiempo: 12 weeks
|
Change in body weight between the intervention and control arms.
|
12 weeks
|
Insulin sensitivity
Periodo de tiempo: 12 weeks
|
Change insulin sensitivitiy assessed by OGTT between the intervention and control arms.
|
12 weeks
|
Diabetes medications
Periodo de tiempo: 12 weeks
|
Change in diabetes medications between the intervention and control arms.
|
12 weeks
|
Inflammatory markers
Periodo de tiempo: 12 weeks
|
Change in TNF-alpha in pg/mL between the intervention and control arms.
|
12 weeks
|
Inflammatory markers
Periodo de tiempo: 12 weeks
|
Change in IL-10 in pg/mL between the intervention and control arms.
|
12 weeks
|
Inflammatory markers
Periodo de tiempo: 12 weeks
|
Change in IL-6 in pg/mL between the intervention and control arms.
|
12 weeks
|
Inflammatory markers
Periodo de tiempo: 12 weeks
|
Change in IL-18 in pg/mL between the intervention and control arms.
|
12 weeks
|
Inflammatory markers
Periodo de tiempo: 12 weeks
|
Change in CRP in mg/L between the intervention and control arms.
|
12 weeks
|
Inflammatory markers
Periodo de tiempo: 12 weeks
|
Change in adiponectin in µg/mL the intervention and control arms.
|
12 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
- RA HM-2019-012
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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