Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Sponsor No. 150 Central Hospital of the Chinese People Liberation Army
Start date October 2010
End date October 2012
Trial size 50 participants
Trial identifier NCT01870713, 150CTSX001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
Participants who have type 2 diabetes and with decreased glucose after gastric bypass surgery.
Participants who are overweight to moderately obese, and have no personal of family history of Type 1, Type 2, or Gestational Diabetes.

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.
time frame: base line to 3 months

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by No. 150 Central Hospital of the Chinese People Liberation Army.