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

Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01870713

Enrollment

Registered

2013-06-06

Start date

2010-10-31

Completion date

2013-10-31

Last updated

2013-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

gastric bypass surgery, proteomics

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery.	base line to 3 months

Secondary

Measure	Time frame
evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.	1 year

Countries

China

Outcome results