- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01870713
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Henan
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Luoyang, Henan, China, 471000
- No. 150 Central hospital of Chinese People's Liberation Army
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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type 2 diabetes patients with gastric bypass surgery.
Participants who have type 2 diabetes and with decreased glucose after gastric bypass surgery.
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Weight matched non-operated controls
Participants who are overweight to moderately obese, and have no personal of family history of Type 1, Type 2, or Gestational Diabetes.
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What is the study measuring?
Primary Outcome Measures
Outcome 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.
Time Frame: base line to 3 months
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base line to 3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150CTSX001
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