Type 2 DiabetesPhase 4NCT01435980
Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes
A Phase 4 study testing Gastric Bypass and Exenatide in people with Type 2 Diabetes, run by Wu Qinan at 1 site in China.
Trial summary
Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass and Exenatide. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Gastric Bypass and Exenatide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2008to Feb 2016
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 35kg/m2, With Type 2 Diabetes;
- BMI32-34.9kg/m2, With Type 2 Diabetes, Insulin Therapy in Combination With Oral Administration of Drugs for 6 Months and HbA1c ≥ 7%;
- Between the Ages of 18-60 Years;
- Course of Type 2 Diabetes ≤ 5 Years;
- ICA, IAA, GAD Are Negative , C-peptide Level is Not Less Than 0.3mg / L;
Who cannot join
- non-diabetic patients , type 1 diabetes (serum insulin antibodies (ICA) or glutamic acid decarboxylase antibodies (GADA)-positive autoimmune diabetes), special type of diabetes, gestational diabetes;
- patients who had liver or renal failure
- severe infections in patients and patients who had cerebrovascular disease
- patients who had heart failure
- fasting serum insulin or 2-hour postprandial serum insulin were lower than normal (<20mmol / L)
- course of diabetes> 5 years or age> 60 years or age <18 years
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Endocrine Department, the south west Hospital of the Third Military Medical University
Chongqing, Chongqing Municipality, 400038
wu qi nan, master, 13452867542 ext. 02368765216, wqn11@126.com
liang zi wen, doctor
About this study
Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass and Exenatide.
Read the detailed description
Methods:
60 Type 2 diabetes in our hospital will divide into 3 groups: group A (20 patients who give basal treatment), group B (20 patients who give basal and Exenatide treatment, group C（20 patients who give basal and Gastric Bypass treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, ejection fraction (EF), fractional shortening(FS), diameter of left ventricle in late diastolic stage(LVEDd), the thickness of the ventricular septa（IVSD) and the posterior wall of the right ventricle in late diastolic stage (LVPWd) will record respectively. Left ventricular mass index (LVMI), relative wall thickness (RWT) will calculate and High-sensitive C-reactive protein (HsCRP), adiponectin and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.
- Conditions
- Type 2 Diabetes
- Being tested
- Gastric Bypass, Exenatide
- Keywords
- type 2 diabetes, Gastric Bypass, GLP-1, adiponectin
- 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.
Gastric BypassProcedure or surgery
Also called basal treatment + Gastric Bypass
basal treatment and Gastric Bypass
ExenatideDrug
Also called basal treatment + Exenatide
basal treatment and Exenatide
| Study group | Role | What they receive |
|---|---|---|
| basal treatment | No intervention | basal treatment |
| Gastric Bypass | Experimental | basal treatment and Gastric Bypass Receives: Procedure: Gastric Bypass |
| Exenatide | Experimental | basal treatment and Exenatide Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical events
Participant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events.
Measured: 1 year
Secondary outcomes (7)
echocardiography
Left ventricular mass index (LVMI)
Measured: 1 year
echocardiography
relative wall thickness (RWT)
Measured: 1 year
Blood testing
High-sensitive C-reactive protein (HsCRP)
Measured: 1 year
Blood testing
homeostasis model assessment(HOMA-IR)
Measured: 1 year
Blood testing
adiponectin
Measured: 1 year
Blood pressure monitoring
blood pressure
Measured: 1 month
Blood testing
glycosylated hemoglobin A1c（HbA1c）
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 posted19 Sep 2011 (estimated)
- Study startFeb 2008
- Primary completionJan 2016 (estimated)
- Study completionFeb 2016 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wu Qinan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wu Qinan, Third Military Medical University
- Investigators
- liang zi wen, doctor, Principal investigator, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435980
- Sponsor's protocol ID
- the south west Hospital2
- Status last verified
- Mar 2015
- First submitted
- 8 Sep 2011
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Comparison the Treatment Effect Between Gastric Bypass and Exenatide in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01435980
- Acronym / sponsor ID
- the south west Hospital2
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, Gastric Bypass, GLP-1, adiponectin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wu QinanUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 19 Sep 2011 (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.
Objectives: To investigate the treatment effect between Gastric Bypass and Exenatide in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism of Gastric Bypass and Exenatide.
Detailed description
Methods:
60 Type 2 diabetes in our hospital will divide into 3 groups: group A (20 patients who give basal treatment), group B (20 patients who give basal and Exenatide treatment, group C（20 patients who give basal and Gastric Bypass treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, ejection fraction (EF), fractional shortening(FS), diameter of left ventricle in late diastolic stage(LVEDd), the thickness of the ventricular septa（IVSD) and the posterior wall of the right ventricle in late diastolic stage (LVPWd) will record respectively. Left ventricular mass index (LVMI), relative wall thickness (RWT) will calculate and High-sensitive C-reactive protein (HsCRP), adiponectin and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| basal treatment | No intervention | –basal treatment |
| Gastric Bypass | Experimental | Procedure: Gastric Bypassbasal treatment and Gastric Bypass |
| Exenatide | Experimental | Drug: Exenatidebasal treatment and Exenatide |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI ≥ 35kg/m2, With Type 2 Diabetes;
- BMI32-34.9kg/m2, With Type 2 Diabetes, Insulin Therapy in Combination With Oral Administration of Drugs for 6 Months and HbA1c ≥ 7%;
- Between the Ages of 18-60 Years;
- Course of Type 2 Diabetes ≤ 5 Years;
- ICA, IAA, GAD Are Negative , C-peptide Level is Not Less Than 0.3mg / L;
Key exclusion criteria (6 listed)
- non-diabetic patients , type 1 diabetes (serum insulin antibodies (ICA) or glutamic acid decarboxylase antibodies (GADA)-positive autoimmune diabetes), special type of diabetes, gestational diabetes;
- patients who had liver or renal failure
- severe infections in patients and patients who had cerebrovascular disease
- patients who had heart failure
- fasting serum insulin or 2-hour postprandial serum insulin were lower than normal (<20mmol / L)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric BypassAlso: basal treatment + Gastric Bypassbasal treatment and Gastric Bypass | Procedure or surgery | Gastric Bypass |
| ExenatideAlso: basal treatment + Exenatidebasal treatment and Exenatide | Drug | Exenatide |
Primary outcome
Clinical events
Time frame: 1 year
Participant with stroke or Myocardial infarction or acute diabetic complication or Liver and renal failure or death or other Adverse Events.
7 secondary outcomes
echocardiography
Time frame: 1 year
echocardiography
Time frame: 1 year
Blood testing
Time frame: 1 year
Blood testing
Time frame: 1 year
Blood testing
Time frame: 1 year
Blood pressure monitoring
Time frame: 1 month
Blood testing
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 27 Mar 2015.
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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.
liang zi wen, doctor principal investigator
Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gastric Bypass and Exenatide in people with Type 2 Diabetes, run by Wu Qinan 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 5 inclusion and 6 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 27 Mar 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact wu qi nan, master (13452867542 ext. 02368765216, wqn11@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical events (time frame: 1 year). 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 27 Mar 2015.