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

NCT ID: NCT01870713

Last Updated: 2013-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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No. 150 Central Hospital of the Chinese People Liberation Army

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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No. 150 Central hospital of Chinese People's Liberation Army

Luoyang, Henan, China

Site Status

Countries

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China

Other Identifiers

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150CTSX001

Identifier Type: -

Identifier Source: org_study_id

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