Type 2 DiabetesNCT01870713
Proteomics Study of Gastric Bypass Surgery to Treat Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes, run by No. 150 Central Hospital of the Chinese People Liberation Army at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Oct 2013
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: all patients are recruited from No. 150 Central Hospital of PLA
Who may be able to join
- patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass
- age:18-65yr
- HbAlc>8%
Who cannot join
- diabetes (applies for control patients)
- chronic inflammatory disease
- malignant disease
- pregnancy
- prior gastric, duodenal, proximal jejunal surgery or pancreas resection
- current use of thiazolidinediones
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
No. 150 Central hospital of Chinese People's Liberation Army
Luoyang, Henan, 471000
About this study
Official title: Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China
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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Keywords
- gastric bypass surgery, proteomics
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
different proteins detected between obese persons, type 2 diabetes patients prior to surgery, 10 days after surgery and 3 months after surgery.
Measured: base line to 3 months
Secondary outcomes (1)
evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- No. 150 Central Hospital of the Chinese People Liberation Army
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870713
- Sponsor's protocol ID
- 150CTSX001
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 6 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Proteomics Research in Bypassing Surgery to Treat Type 2 Diabetes in China
- ClinicalTrials.gov ID
- NCT01870713
- Acronym / sponsor ID
- 150CTSX001
- Conditions
- Type 2 Diabetes
- Keywords
- gastric bypass surgery, proteomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- No. 150 Central Hospital of the Chinese People Liberation ArmyOther government
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2013 (estimated)
- First posted
- 6 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- all patients are recruited from No. 150 Central Hospital of PLA
Key inclusion criteria (3 listed)
- patients diagnosed as type 2 diabetes are planning to have Roux-en-Y gastric bypass
- age:18-65yr
- HbAlc>8%
Key exclusion criteria (9 listed)
- diabetes (applies for control patients)
- chronic inflammatory disease
- malignant disease
- pregnancy
- prior gastric, duodenal, proximal jejunal surgery or pancreas resection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
evaluating the change in glucose between the baseline evaluation and the follow-up evaluation.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by No. 150 Central Hospital of the Chinese People Liberation Army at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2013.