Clinical trial NCT01870713: Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus
Official title: Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes
Keywords: gastric bypass surgery
proteomics
Lead sponsor: No. 150 Central Hospital of the Chinese People Liberation Army
Sponsor class: OTHER_GOV
First posted: 2013-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients are recruited from No. 150 Central Hospital of PLA

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.

Eligibility criteria: 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

Primary outcomes:
measure: different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery.
timeFrame: base line to 3 months
Secondary outcomes:
measure: evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.
timeFrame: 1 year
Other outcomes:
Locations:
city: Luoyang
country: China
facility: No. 150 Central hospital of Chinese People's Liberation Army
state: Henan
Study officials:
References: