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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02091323
Effect of Laparoscopic Roux-en-Y Gastric Bypass Surgery on Non-severe Obesity With Type 2 Diabetes Mellitus
25 de enero de 2015 actualizado por: Wu Liangping, Guangzhou General Hospital of Guangzhou Military Command
Effect of Modified Laparoscopic Roux-en-Y Gastric Bypass Surgery on Type 2 Diabetics With Lower Body Mass Index in China
The effect of roux-en-Y gastric bypass(RYGB) on patients with type 2 diabetes mellitus(T2DM) and a body mass index(BMI)>35kg/m2 is clear.
There are large-scale patients with T2DM in Chinese population and currently about two-thirds of them are lack of adequate blood glucose control.
Asian Chinese have different type of obesity, different style of diet, and a relatively low BMI levels as well.
We assess the feasibility and efficacy of laparoscopic roux-en-Y gastric bypass surgery (LRYGB) in patients with non-severely obese T2DM.Taking into account the differences of body size and diet between the United States & Europe and Asian countries, diabetic situation has its special features in different regions, especially in Asia China.
Asian Chinese have a high incidence of T2DM and a relatively low BMI levels.
Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become necessary.The patients will be followed up for one year after surgery and a comparison would be made between the two groups.
Clinical indicators that reflect the effect of LRYGB are monitored before surgery and 1, 3,6,12 months after surgery.
Complete remission of diabetes was defined by hemoglobin A1c (HbA1c)<6.0%
and Fasting plasma glucose (FPG)<5.6mmol/L.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Type 2 diabetes mellitus (T2DM) is well known as a chronic metabolic disease.
As the main manifestation of T2DM , the disorder of glucose metabolism which is due to the gradual dysfunction of pancreatic islet and significant insulin resistance results in many problems and complications associated with T2DM such as hypertension, cardiovascular diseases(CVD), lipid disorders and other complications.
Currently, there are more than 346 million people suffered from T2DM worldwide, among which T2DM accounts for about 90%.
A report published by Chinese diabetes and metabolic syndrome research group in 2010 showed that overall prevalence of diabetes is 9.7% over the age of 20 and the total number of diabetes mellitus has reached 92.4 million in Chinese population and what's worse, more than 15.5 percent of adults are in the pre-diabetic state.
Through traditional diet therapy, exercise, changing lifestyle, and standardized medical treatment have a certain effect on diabetes and its complications, T2DM can't be cured so far.
How to cure diabetes mellitus and improve the quality of life of diabetic patients is a common problem faced by doctors in all countries.
In 1984, Pories et al have found that glucose metabolism indicators significantly improved when he analyzed a report of three-year progress results of obesity patients with T2DM after laparoscopic Roux-en-Y gastric bypass surgery(LRYGB) , thus opening a door to the surgical treatment for diabetes.
Now LRYGB is often performed in Europe and United State, and has been written into the diabetes treatment guidelines by American Diabetes Association in 2009.
The surgical treatment for diabetes is an extension from the surgical treatment for morbid obesity.
So diabetes treatment guidelines in 2014 show that bariatric surgery may be considered for T2DM with a body mass index (BMI) >35 kg/m2, especially if diabetes or associated comorbidities are difficult to control with lifestyle and pharmacological therapy.
However, it also mentioned that small trials have shown benefit in patients with type 2 diabetes mellitus and BMI 30-35 kg/m2 after bariatric surgery.
But it still lacks sufficient evidence for patients with BMI below 30kg/m2.
A survey conducted in Shanghai, China, showed that the prevalence of type 2 diabetes was 9.8%, while the prevalence of obesity was 4.3%.But in the United States, the incidence of type 2 diabetes was 10.9% and the obesity population defined by a BMI ≥30 kg/m2 may account for one third of the total population in 2009-2010.
In addition, patients in Asian countries are mostly abdominal obesity compared with that of patients in the United States and Europe where have different type of obesity.
Taking into account the differences of body size and diet between the United States & Europe and Asian countries, diabetic situation has its special features in different regions, especially in Asia China.
Asian Chinese have a high incidence of T2DM and a relatively low BMI levels.
Evaluating the benefits from LRYGB for T2DM in Asian Chinese diabetes subjects with a body mass index of less than 35kg/m2 and looking for sufficient evidence to this operation become necessary.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510010
- Reclutamiento
- WU
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Contacto:
- Liangping Wu
- Correo electrónico: drwulp@163.com
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Contacto:
- Yongtao Huang
- Correo electrónico: zsh2014@foxmail.com
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Investigador principal:
- Yongtao Huang
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria: In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose(PG) ≥200 mg/dL(11.1 mmol/L) or fasting plasma glucose (FPG) ≥ 7 .0 mmol / L or Two-hour PG ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test(OGTT) or HbA1c > 6.5% .The study candidates were included if they had any of the following features:
- exclusion of type 1 diabetes mellitus(T1DM) ;
- BMI ≤ 35 kg/㎡ or waist circumference >90cm;
- duration of T2DM less than 15 years ;
- age ≤ 65 years ;
- islet functional reserve :fasting C-peptide (FC-P) normal or more , postprandial two-hour C-peptide response more than 2 times compared with a pre-dinner ;
- poor control of medical treatment ,glycated hemoglobin (HbA1c) ≥ 7 .0%;
- volunteer to accept LRYGB surgery and sign the consent
Exclusion Criteria:
- type 1 diabetes mellitus
- age >65 years
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: BMI<28kg/m2
Indicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI<28kg/m2 group.
|
With the patient under intubation and general anesthesia, a pneumoperitoneum was created and the pressure was set to 15 mmHg.
All LRYGB operations were performed using four trocars.
Separate cardiac angle and hepatogastric ligament from the left gastric artery between 2 and 3 branch by hanging liver on the abdominal wall so as to enter into the lesser sac.
Reveal the ligament of Treitz, lift the jejunum from the Treitz ligament 75 ~ 150 cm, connect the distal jejunum to the posterior wall of the stomach with a linear cutting staple by an end-to-side anastomosis and suture the common opening at last.
Otros nombres:
|
Otro: control
Indicators monitored preoperatively and at 1,3,6,12 months after surgery in BMI>28kg/m2 group as well.
|
With the patient under intubation and general anesthesia, a pneumoperitoneum was created and the pressure was set to 15 mmHg.
All LRYGB operations were performed using four trocars.
Separate cardiac angle and hepatogastric ligament from the left gastric artery between 2 and 3 branch by hanging liver on the abdominal wall so as to enter into the lesser sac.
Reveal the ligament of Treitz, lift the jejunum from the Treitz ligament 75 ~ 150 cm, connect the distal jejunum to the posterior wall of the stomach with a linear cutting staple by an end-to-side anastomosis and suture the common opening at last.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
fasting plasma glucose(FPG)
Periodo de tiempo: up to 36 months after surgery
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up to 36 months after surgery
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
hemoglobin A1c (HbA1c)
Periodo de tiempo: HbA1c will be monitored preoperatively and at 1,3,6,12 ,24,36months after surgery
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HbA1c will be monitored preoperatively and at 1,3,6,12 ,24,36months after surgery
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
---|---|
weight loss
Periodo de tiempo: weight loss will be monitored preoperatively and at 1,3,6,12,24,36 months after surgery
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weight loss will be monitored preoperatively and at 1,3,6,12,24,36 months after surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Cotillard A, Poitou C, Duchateau-Nguyen G, Aron-Wisnewsky J, Bouillot JL, Schindler T, Clement K. Type 2 Diabetes Remission After Gastric Bypass: What Is the Best Prediction Tool for Clinicians? Obes Surg. 2015 Jul;25(7):1128-32. doi: 10.1007/s11695-014-1511-8.
- Luger M, Kruschitz R, Langer F, Prager G, Walker M, Marculescu R, Hoppichler F, Schindler K, Ludvik B. Effects of omega-loop gastric bypass on vitamin D and bone metabolism in morbidly obese bariatric patients. Obes Surg. 2015 Jun;25(6):1056-62. doi: 10.1007/s11695-014-1492-7.
- Torriani M, Oliveira AL, Azevedo DC, Bredella MA, Yu EW. Effects of Roux-en-Y gastric bypass surgery on visceral and subcutaneous fat density by computed tomography. Obes Surg. 2015 Feb;25(2):381-5. doi: 10.1007/s11695-014-1485-6.
- Chen Y, Zeng G, Tan J, Tang J, Ma J, Rao B. Impact of roux-en Y gastric bypass surgery on prognostic factors of type 2 diabetes mellitus: meta-analysis and systematic review. Diabetes Metab Res Rev. 2015 Oct;31(7):653-62. doi: 10.1002/dmrr.2622. Epub 2014 Dec 17.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de marzo de 2014
Finalización primaria (Anticipado)
1 de diciembre de 2016
Finalización del estudio (Anticipado)
1 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
12 de marzo de 2014
Primero enviado que cumplió con los criterios de control de calidad
18 de marzo de 2014
Publicado por primera vez (Estimar)
19 de marzo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
27 de enero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
25 de enero de 2015
Última verificación
1 de enero de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Lrygb2014
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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