NCT01870713

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 4, 2013

Last Update Submit

June 4, 2013

Conditions

Type 2 Diabetes

Keywords

gastric bypass surgeryproteomics

Outcome Measures

Primary Outcomes (1)

  • different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery.

    base line to 3 months

Secondary Outcomes (1)

  • evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.

    1 year

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients are recruited from No. 150 Central Hospital of PLA

You may qualify if:

  • patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass
  • age:18-65yr
  • HbAlc\>8%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Luoyang, Henan, 471000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2013

First Posted

June 6, 2013

Study Start

October 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2013

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

CN(1)