Longitudinal Cohort Study Comparing 2 Surgical Techniques in Patients With Class 3 Obesity and Type 2 Diabetes (OBEDIAB)
Longitudinal Cohort Study Comparing 2 Surgical Techniques (Roux-en-Y Gastric Bypass and Adjustable Gastric Banding) in Patients With Class 3 Obesity and Type 2 Diabetes
Wight loss surgery provides good glycemic control in type 2 diabetes. The technique of "Roux-en-Y gastric bypass" is more effective than the "Adjustable Gastric Band" on weight loss.
This longitudinal cohort study will compare the effectiveness of the Roux-en-Y gastric bypass and Adjustable Gastric Banding on glycemic control in type 2 diabetes and explore the responsible mechanisms.
The evaluation will be made preoperatively and 1 year later as assessed by the decline in HbA1c. An evaluation will also be carried out after a weight loss of 10% to indicate whether the observed difference is independent of weight loss.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Type 2 diabetes is a condition often associated with obesity and often difficult to control. In patients with severe obesity, surgical treatment allows a sustainable weight loss and higher than that obtained with other treatments available. In most cases, surgery also reduces significantly the comorbidities of obesity and diabetes in particular. Among the various technical options, adjustable gastric band (AGB) is the simplest and by far the most used in France.
Roux-en-Y gastric bypass (RYGB) is a more complicated intervention combining gastrointestinal malabsorption- duodeno-jejunal and gastric reduction and allows a higher weight loss. Several studies also suggest that the technique has a remarkable efficiency on glycemic control, justifying the extension of its readings/indications. No study controlled, however, has compared these two techniques.
The objective of this study is to compare the efficiency of RYGB vs AGB on glycemic control in type 2 diabetes. Although some studies have compared AGB and RYGB, none have compared their effectiveness on post prandial glucose control in patients with diabetes. It is generally recognized that the effectiveness of RYGB on diabetes is independent of the weight loss, but this has never been demonstrated.
By demonstrating the superiority of RYGB vs AGB, and identifying the responsible mechanisms, the study will expand the indications of RYGB in the treatment of type 2 diabetes. Weight loss surgery offers a unique model for the clinical study of the pathophysiology of type 2 diabetes.
Main objective:
- To compare the effectiveness of RYGB vs AGB on glucose control in obese patients with type 2 diabetes.
Secondary Objectives:
- demonstrate that the better outcome achieved with RYGB is independent of weight loss.
- Identify the mechanisms underlying the better outcome of RYGB
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Nord
-
Lille, Nord, Francia, 59037
- Lille University Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Candidate for bariatric surgery (Roux-en-Y gastric bypass OR adjustable gastric band) with class 3 obesity (body mass index ≥ 35 kg/m2) and type 2 diabetes (ADA definition)
OR healthy volunteers
Descripción
Inclusion Criteria:
- Age between 18 and 70 years AND
- BMI > 35
- Type 2 diabetes
- Obesity for more than 5 years OR
- normoglycemia
- BMI< 30
Exclusion Criteria:
- Secondary obesity due to an endocrinopathy
- Chronic pathology (neoplasia, cirrhosis, disease of system)
- Psychosis, alcoholic addiction or narcotics.
- Contre-indications to the anaesthesia
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Roux-en-Y gastric bypass
Patients with class 3 obesity and type 2 diabetes submitted to Roux-en-Y gastric bypass
|
Laparoscopic Roux-en-Y gastric bypass
Otros nombres:
|
|
Adjustable gastric banding
Patients with class 3 obesity and type 2 diabetes submitted to adjustable gastric banding
|
Laparoscopic adjustable gastric band
Otros nombres:
|
|
Healthy controls
Non-obese, non-diabetic adults
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glucose control
Periodo de tiempo: 12 months
|
HbA1c and fasting blood glucose
|
12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glycaemia, Insulinemia, Incretins during a standardized meal test at 10% of weight loss
Periodo de tiempo: 3 months
|
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
|
3 months
|
|
Weight loss
Periodo de tiempo: 60 months
|
Body mass index
|
60 months
|
|
Glycaemia, Insulinemia, Incretins, and D-xylose during a normalized(standardized) meal
Periodo de tiempo: 12 months
|
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
|
12 months
|
|
Glycaemia, insulinemia, incretins, and D-xylose during a normalized(standardized) meal
Periodo de tiempo: 60 months
|
Concentration curves of glycaemia, insulinemia, incretins, and D-xylose during a standardized mixed meal test
|
60 months
|
|
Diabetes remission
Periodo de tiempo: 60 months
|
HbA1c < 6.5% AND fasting blood glucose < 7.0 mmol/L in absence of antidiabetic drug
|
60 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Francois PATTOU, Lille University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- DGS 2004/0123
- 2004/0412 (Otro identificador: sponsor)
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