Diet and Exercise Intervention in Type 2 Diabetes (LID)
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Missouri
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Saint Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 25-68 yrs old
- BMI 27.0-50.0 kg/m²
- Diagnosis of type 2 diabetes based on HbA1C>6.5% or results of an oral glucose tolerance test or current use of anti-diabetic medications
- HbA1C ≤9.5 %.
- Work at Washington University in St. Louis, Barnes Jewish Hospital, St. Louis Children's Hospital, Shriners, St. Louis College of Pharmacy, Central Institute for the Deaf, Rehabilitation Institute of St. Louis, and/or any institutions affiliated with these.
Exclusion Criteria:
- Any change in diabetes medication in previous 3 months
- Treated with >0.5 units of insulin/kg body weight per day
- Unstable weight (>2% change during the last 2 months before entering the study)
- History or evidence of serious pulmonary or cardiovascular disease, including acute coronary syndrome, heart failure requiring medications, or New York Heart Association class III heart failure (patients with marked limitation of activity and who are comfortable only at rest) or IV heart failure (patients who should be at complete rest, confined to bed or chair and who have discomfort with any physical activity).
- Evidence of serious cardiac abnormalities during exercise stress testing that increase cardiac risk of initiating an exercise program.
- Creatinine >1.5 mg/dL
- Microalbuminuria; spot urine albumin:creatinine ratio >50 (50 μg albumin/mg creatinine)
- Coagulation disorders
- Anemia (Hemoglobin <10.0 g/dL)
- Liver enzymes (ALT and AST) ≥3 times the upper limit of normal
- Uncontrolled proliferative diabetic retinopathy
- Severe peripheral neuropathy diagnosed by monofilament testing
- Severe organ dysfunction
- Pregnant or breastfeeding
- Participating in regular exercise (>1 h of structured exercise/week)
- Joint replacement within the last year
- Smokes tobacco
- Severe lactose intolerance
- Take any medication that might interfere with interpretation of the metabolic studies
- Unable or unwilling to follow the study protocol or for any reason the research team believes the volunteer is not an appropriate candidate for this study, including non-compliance with screening appointments or previous medical visits.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Otro: Standard Care
Participants randomized to this arm will receive dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines.
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After receiving dietary and physical activity instructions as recommended by the American Diabetes Association (ADA) guidelines participants will meet approximately every month for about 7 months with a study team member to record body weight, review diet and physical activity behaviors, and document medication use.
Participants will continue their routine medical management, including regular clinic visits with their personal physician and/or diabetes educator during their participation in this study.
Any changes medications will made by the participants' personal physician(s).
|
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Experimental: Intensive Lifestyle intervention
Participants randomized to this arm will be participate in weekly dietary and behavioral education session in addition to four 60-min supervised exercise training sessions per week for 8 months.
All dietary and- behavioral education and exercise training sessions will be conducted at the worksite.
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Participants will be instructed to consume ~500 kcal/day less than their calculated estimated total daily energy requirements.
The supervised exercise program will include both endurance and resistance exercise training sessions.
The doses of diabetes medications will be adjusted by study physicians every 1-2 weeks, as needed to avoid hypoglycemia.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Skeletal muscle insulin sensitivity
Periodo de tiempo: 7-8 months
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Skeletal muscle insulin sensitivity will be calculated as the glucose disposal rate per kg fat-free mass divided by plasma insulin during a hyperinsulinemic-euglycemic clamp procedure.
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7-8 months
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Liver insulin sensitivity
Periodo de tiempo: 7-8 months
|
Liver insulin sensitivity will be assessed by using the hepatic insulin sensitivity index.
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7-8 months
|
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Adipose tissue insulin sensitivity
Periodo de tiempo: 7-8 months
|
Adipose tissue insulin sensitivity will be assessed by using the adipose tissue insulin sensitivity index.
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7-8 months
|
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β-cell function
Periodo de tiempo: 7-8 months
|
β-cell function will be assessed from a modified oral glucose tolerance test
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7-8 months
|
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Insulin clearance
Periodo de tiempo: 7-8 months
|
Insulin clearance will be assessed from a modified oral glucose tolerance test
|
7-8 months
|
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Diabetes remission
Periodo de tiempo: 7-8 months
|
Remission of type 2 diabetes will be defined as HbA1c <6.0% without the use of diabetes medications use of diabetes medications.
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7-8 months
|
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Cardiorespiratory fitness
Periodo de tiempo: 7-8 months
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Peak oxygen consumption will be assessed using indirect calorimetry during a graded exercise test to volitional exhaustion.
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7-8 months
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Muscle strength
Periodo de tiempo: 7-8 months
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Muscle strength will be assessed as the total maximal weight lifted during the 1 repetition maximum tests for leg press, knee flexion, seated row, and chest press exercises.
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7-8 months
|
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Whole-body fat mass
Periodo de tiempo: 7-8 months
|
Total body fat mass will be assessed by dual-energy X-ray absorptiometry.
|
7-8 months
|
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Whole-body fat-free mass
Periodo de tiempo: 7-8 months
|
Fat-free mass will be assessed by dual-energy X-ray absorptiometry.
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7-8 months
|
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Appendicular lean mass
Periodo de tiempo: 7-8 months
|
Appendicular lean mass will be assessed by dual-energy X-ray absorptiometry.
|
7-8 months
|
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Intra-abdominal adipose tissue volume
Periodo de tiempo: 7-8 months
|
Intra-abdominal adipose tissue volume will be determined by using magnetic resonance imaging.
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7-8 months
|
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Intrahepatic triglyceride content
Periodo de tiempo: 7-8 months
|
Intrahepatic triglyceride content will be determined by using magnetic resonance spectroscopy.
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7-8 months
|
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Plasma adipokine concentrations
Periodo de tiempo: 7-8 months
|
Plasma adiponectin and PAI-1 concentrations will be measured in the Washington University Clinical Core Laboratory.
|
7-8 months
|
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Transcriptome in muscle and adipose tissue
Periodo de tiempo: 7-8 months
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The transcriptome (all RNA that are responsible for making proteins from DNA templates) will be evaluated by using RNA sequencing techniques.
|
7-8 months
|
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Skeletal muscle mitochondrial metabolites
Periodo de tiempo: 7-8 months
|
The content of muscle mitochondrial-related metabolites will be determined by liquid chromatography mass spectrometry.
|
7-8 months
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Yoshino M, Yoshino J, Smith GI, Stein RI, Bittel AJ, Bittel DC, Reeds DN, Sinacore DR, Cade WT, Patterson BW, Cho K, Patti GJ, Mittendorfer B, Klein S. Worksite-based intensive lifestyle therapy has profound cardiometabolic benefits in people with obesity and type 2 diabetes. Cell Metab. 2022 Oct 4;34(10):1431-1441.e5. doi: 10.1016/j.cmet.2022.08.012. Epub 2022 Sep 8.
- Mittendorfer B, Patterson BW, Smith GI, Yoshino M, Klein S. beta Cell function and plasma insulin clearance in people with obesity and different glycemic status. J Clin Invest. 2022 Feb 1;132(3):e154068. doi: 10.1172/JCI154068.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 201302095
Información sobre medicamentos y dispositivos, documentos del estudio
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