Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus

No. 150 Central Hospital of the Chinese People Liberation Army

Status: Unknown

Conditions: Type 2 Diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT01870713

150CTSX001

Details and patient eligibility

About

The purpose of this study is to reveal the key proteins involved in gastric bypassing surgery which may effect the decreased glucose in type 2 diabetes patietns, and evaluate standard remission rate as well as cost-benefit of gastric bypassing surgery for type 2 diabetes mellitus patients in China.

Full description

Diabetes Mellitus is a major global problem which responsibles for 4.6 million deaths each year without effective therapy methods. Recently，researchers showed that type 2 diabetes mellitus can be partly reversed by gastric bypassing surgery. However, surgeons are still not clear how to chose the proper diabetes patients for surgery as the mechanism is still not clear, and the remission rate of diabetes mellitus is not the same among different surgical procedures.

This study will enroll type 2 diabetes mellitus patients follwing Roux-en-Y gastric bypassing surgery and obese persons without type 2 diabetes surgery. The defferent expressions of serum proteins of obese persons without type 2 diabetes and type 2 diabetes patients following gastric bypassing surgery after 10 days or 3 months were detected by serum proteomics. Blood samples and urine will be taken prior to surgery, 10 days after surgery and 3 months after surgery. The long term prognosis of diabetes mellitus for 1 years and the remission rate of diabetes of patients will be evaluated.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass
• age:18-65yr
• HbAlc>8%

Exclusion criteria

• diabetes (applies for control patients)
• chronic inflammatory disease
• malignant disease
• pregnancy
• prior gastric, duodenal, proximal jejunal surgery or pancreas resection
• current use of thiazolidinediones
• treatment with incretin mimetics or DPP IV inhibitors in the prior 3 months
• HbAlc<8%
• any condition felt by the investigator to interfere with ability to complete the study

Trial design

50 participants in 2 patient groups

type 2 diabetes patients with gastric bypass surgery.

Description:

Participants who have type 2 diabetes and with decreased glucose after gastric bypass surgery.

Weight matched non-operated controls

Description:

Participants who are overweight to moderately obese, and have no personal of family history of Type 1, Type 2, or Gestational Diabetes.