Influence of the Use of Specific Nutritional Formulas on Time in Range in Patients With Type 2 Diabetes
Influence of the Use of Specific Nutritional Formulas for Diabetes on Time in Range in Patients With Type 2 Diabetes Mellitus With Obesity by Freestyle Continuous Glucose Monitoring
Who can participate?
Individuals may be eligible to join this study if they meet the following criteria:
- Are 18 years or older.
- Have Type 2 diabetes with an A1c level higher than 7%.
- Have a Body Mass Index (BMI) between 27 and 35 (considered overweight or Class 1 obesity).
- Have used a continuous glucose monitor (CGM) successfully in the past.
How the study works:
If eligible individuals decide to join and sign the consent form, a computer will randomly assign them into one of two groups:
The Formula Group: Participants will replace their usual breakfast and one snack with a specific diabetes nutritional drink (Glucerna®).
The Standard Diet Group: Participants will follow a standard low-calorie meal plan without using the nutritional drink.
Both groups will aim for a specific daily calorie goal (1,200-1,500 for women; 1,500-1,800 for men) and will receive expert nutritional counseling.
Monitoring and Follow-up
Over the course of 3 months, close contact will be maintained to support participants:
Every 2 weeks: A nutrition expert will call participants to check on their diet and help with their glucose monitor.
Every month: Participants will meet with the study team in person to review glucose monitor data.
Tests: At the start and end of the study, weight, body composition, blood sugar (A1c), and cholesterol levels will be measured to see how the plans worked.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A randomized controlled clinical trial will be conducted with two parallel groups, which will include patients over 18 years of age with type 2 DM, HbA1c > 7%, and grade 1 obesity (BMI >27 kg/m2 and <35 kg/m2), who have previously used continuous glucose monitoring (CGM) with adherence greater than 70%, and who are able to follow the study protocol.
After signing the informed consent, REDcap® will be used to computer-generate the random sequence for group assignment; the intervention group will use a specific nutritional formula for diabetes (FNED) (Glucerna®) (Appendix 1) as a replacement for breakfast and snack to achieve targets of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men, and the control group will continue to be prescribed a low-calorie diet of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men without the use of FNED for a period of 3 months. Both groups will receive nutritional counseling according to the diabetes support and self-care education plan.
CGM, body composition, and baseline paraclinical variables will be collected, and every 14 days, adherence to dietary treatment will be verified by telephone using a 24-hour multi-step reminder with advice from a dietary team, and correct use of the device will be verified. CGM records are reviewed in person monthly using the LibreView" platform. CGM data, body composition and HbA1c, total cholesterol, HDL, LDL, baseline triglycerides will be analyzed at 3 months of follow-up.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Diana C Henao-Carrillo, Endocrinologyst
- Número de teléfono: 2817 +57 601 5946161
- Correo electrónico: dchenao@husi.org.co
Copia de seguridad de contactos de estudio
- Nombre: Ana M Gómez - Medina, Endocrinologyst
- Número de teléfono: 2817 +57 601 5946161
- Correo electrónico: agomez@husi.org.co
Ubicaciones de estudio
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Cundinamarca
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Bogotá, Cundinamarca, Colombia, 111021
- Hospital Universitario San Ignacio
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Contacto:
- Diana C Henao-Carrillo, Endocrinologyst
- Número de teléfono: 2817 +57 601 5946161
- Correo electrónico: dchenao@husi.org.co
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Contacto:
- Ana M Gómez Medina, Endocrinologyst
- Número de teléfono: 2817 +57 601 5946161
- Correo electrónico: agomez@husi.org.co
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion criteria:
- Patients over 18 years of age.
- Diagnosis of diabetes mellitus type 2.
- HbA1c >7% to <11%.
- BMI >27 kg/mt2 <35 kg/mt2
- Current use of continuous glucose monitoring with adherence greater than 70%.
- Access to technology to download data from CGM in a timely manner.
- Ability to follow the study protocol and provide informed consent (Appendix 3).
Exclusion criteria:
- Change in antidiabetic medication in the last 3 months.
- Pregnancy or lactation or planning to become pregnant during the study period.
- Acute decompensation of diabetes in the past 3 months.
- Participation in another clinical trial.
- Use of glucocorticoids or insulin in the past 3 months or planned use in the coming months.
- Initiation of treatment with oral or injectable GLP-1 analogues 3 months prior to enrollment.
- History of bariatric surgery or gastrointestinal pathology associated with malabsorption syndromes.
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 |
|---|---|
|
Comparador activo: Glucerna
A calorie-restricted diet plan is prescribed (see Table 1).
In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan.
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A calorie-restricted diet plan is prescribed (see Table 1).
In this group, Glucerna will be prescribed for breakfast and snacks as part of the total calories calculated for each patient's meal plan.
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
|
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Comparador de placebos: Placebo
Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
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Dietary plan prescription of 1200 to 1500 kcal for women and 1500 to 1800 kcal for men.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time in range
Periodo de tiempo: 3 months
|
Time in range 70 - 180 mg/dl
|
3 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
HbA1c
Periodo de tiempo: 3 months
|
HbA1c
|
3 months
|
|
Weight
Periodo de tiempo: 3 months
|
Weight in kilograms
|
3 months
|
|
body composition
Periodo de tiempo: 3 months
|
fat mass, musculoskeletal mass, visceral fat mass
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Ana M Gómez-Medina, Endocrinologyst, Hospital Universitario San Ignacio
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Diabetes Mellitus, Tipo 2
- Terapéutica
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Fenómenos fisiológicos nutricionales
- Terapia de dieta
- Terapia nutricional
- Dieta
- Ingesta de energía
- Restricción calórica
- Glucerna
Otros números de identificación del estudio
- FM-CIE-0840-24
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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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