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

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ClinicalTrials.gov Identifier: NCT01870713
Recruitment Status : Unknown
Verified June 2013 by No. 150 Central Hospital of the Chinese People Liberation Army.
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2013
Last Update Posted : June 6, 2013
Sponsor:
Information provided by (Responsible Party):
No. 150 Central Hospital of the Chinese People Liberation Army

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.

Condition or disease
Type 2 Diabetes

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 : Observational [Patient Registry]
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China
Study Start Date : October 2010
Actual Primary Completion Date : October 2012
Estimated Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Group/Cohort
type 2 diabetes patients with gastric bypass surgery.
Participants who have type 2 diabetes and with decreased glucose after gastric bypass surgery.
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. evaluating the change in glucose between the baseline evaluation and the follow-up evaluation. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
whole blood, serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all patients are recruited from No. 150 Central Hospital of PLA
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870713


Locations
China, Henan
No. 150 Central hospital of Chinese People's Liberation Army
Luoyang, Henan, China, 471000
Sponsors and Collaborators
No. 150 Central Hospital of the Chinese People Liberation Army

Responsible Party: No. 150 Central Hospital of the Chinese People Liberation Army
ClinicalTrials.gov Identifier: NCT01870713     History of Changes
Other Study ID Numbers: 150CTSX001
First Posted: June 6, 2013    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by No. 150 Central Hospital of the Chinese People Liberation Army:
gastric bypass surgery
proteomics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases