- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03853590
Improvement of Insulin Resistance After Bariatric Surgery
Mechanisms Underlying the Improvement of Insulin Resistance in Response to Bariatric Surgery
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Bariatric and weight loss surgery is an effective treatment for severe obesity. Bariatric surgery also decreases insulin resistance and improves diabetes. Our study enrolled individuals approved for bariatric surgery to collect data on modifiable predictors and laboratory outcomes. These data would allow us to systematically assess clinical outcomes over one year post bariatric surgery and elucidate how insulin resistance is decreased and diabetes is improved.
The type of surgery was selected by the subjects between Roux-en-Y gastric bypass or a laparoscopic adjustable gastric banding. Participation in the study involved having a small sample of tissue obtained from the abdomen and subjects were also given the option to have a biopsy performed in the thigh area during their elective surgical procedure (optional adipose and muscle tissue biopsies).
Subjects were examined prior to surgery and at 2, 3, 6 months after intervention. Anthropometric and body composition measurements were performed using the Bioelectrical Impendence Analysis (BIA) before surgery and 6 months post operatively. Morning blood was collected after overnight fasting during each visit. Some of the non-diabetic subjects completed a mixed nutrient stimulation study during the baseline and 6-month visit. Blood samples were collected immediately prior to drinking the liquid drink, and every 30 minutes after the meal ingestion for 2 hours.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Beth Israel Deaconess Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- males and females
- 18-65 years old
- approved for bariatric surgery as per BIDMC Bariatric Clinic guidelines
- English-speaking
- willing and able to take part in a multi year study involving telephone interviews and enrolled prior to bariatric surgery
Exclusion Criteria:
Any condition that would exclude a patient from bariatric surgery as listed below:
- patients with untreated major depression or psychosis
- binge eating disorders
- current drug and alcohol abuse
- severe cardiac disease with prohibitive anesthetic risks
- severe coagulopathy
- inability to comply with nutritional requirements including life-long vitamin replacement.
- pregnancy
- Any additional condition not in accordance with standard of care as per Bariatric Clinic at BIDMC.
- Any condition which in the opinion of the investigators rendered the candidate unsuitable for participation in this study.
Exclusion Criteria for Optional Biopsy:
- history of any illness, other than obesity, that may affect insulin sensitivity (diabetes anemia, infectious diseases, renal or hepatic failure, uncontrolled hypertension, cancer or lymphoma)
- subjects who required special diet prior to surgery
- chronic inflammatory conditions such as inflammatory bowel disease and rheumatoid arthritis
- states of cortisol or growth hormone excess
- any medications that are known to influence glucose metabolism such as glucocorticoids
- a known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to anesthetic agents such as Lidocaine or Novocaine
- a known history of bleeding dyscrasia or poor wound healing
- any medical condition precluding supine position
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Laparoscopic Adjustable Gastric Band
Subjects who elected to undergo Laparoscopic Adjustable Gastric Band intervention were examined prior to surgery and at 2, 3, 6 months after operation.
|
Placement of a soft silicone ring with an expandable balloon in the center, around the top part of the stomach to create a two-compartment stomach, with a much smaller top part above the band.
The subject will eat enough food only to fill the top part of the stomach decreasing caloric consumption.
|
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Experimental: Roux-en-Y gastric bypass surgery
Subjects who elected to undergo Roux-en-Y gastric bypass surgery were examined prior to surgery and at 2, 3, 6 months after operation.
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Creation of a small pouch from the stomach and connection of the newly created pouch directly to the small intestine so that swallowed food bypasses most of the stomach and the first section of the small intestine.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
fasting insulin
Periodo de tiempo: Change from Baseline insulin at 6 months post-surgery
|
circulating levels of fasting insulin measured in pmol/L
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Change from Baseline insulin at 6 months post-surgery
|
|
fasting glucose
Periodo de tiempo: Change from Baseline insulin at 6 months post-surgery
|
circulating levels of fasting glucose measured in mg/dl
|
Change from Baseline insulin at 6 months post-surgery
|
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Boost Challenge Test
Periodo de tiempo: Change from Baseline insulin at 6 months post-surgery
|
serum insulin and glucose levels after a mixed meal challenge (Boost Protein shake)
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Change from Baseline insulin at 6 months post-surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christos Mantzoros, MD, PhD, Beth Israel Deaconess Medical Center
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
- 2009P-000216
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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