Non Insulin Dependent Diabetes MellitusT2DMNCT01735253
Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients
A study testing laparoscopic roux en Y gastric bypass / open duodenojejunal bypass in people with Non Insulin Dependent Diabetes Mellitus, run by Inha University Hospital at 1 site in South Korea.
Trial summary
Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Non Insulin Dependent Diabetes Mellitus
- What is being tested?
- laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2009to Oct 2012
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- HbA1C > 7.0%
- BMI 23 - 34 or BMI 21-22 with viceral obesity
- insulin use less than 10 years
- uncerstanding the risks, hypothesis, expecting effects
Who cannot join
- type 1 diabetes
- C-peptide < 1.0ng/ml
- BMI < 21
- severe cardiovascular diseases or their history
- malignancy or history
- alcoholics, pituitary failrue
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- history of severe ketosis, diabetic coma or precoma
- abnormal liver enzyme, over 3 fold of normal level
- liver cirrhosis or hepatitis
- serum creatinine > 2.0mg/dL
- glucocorticoids user
- diabetes due to other endocrine diseases
- pancreatic disease
- anti-GAD Ab (+)
- the incongruity for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Surgery for Type 2 Diabetes
Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese.
We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.
Read more
The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study.
We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.
We will compare the clinical factors at each time.
- Conditions
- Non Insulin Dependent Diabetes Mellitus
- Being tested
- laparoscopic roux en Y gastric bypass / open duodenojejunal bypass
- Keywords
- metabolic surgery, gastric bypass, duodenojejunal bypass, type 2 DM
- 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.
laparoscopic roux en Y gastric bypass / open duodenojejunal bypassProcedure or surgery
routine GBP with 80cm roux and biliopancreatic limb
| Study group | Role | What they receive |
|---|---|---|
| gastric bypass, duodenojejunal bypass | Experimental | Not described Receives: Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
change of the level
Measured: preoperatively, at 3month, at 12 month
Secondary outcomes (1)
oral glucose tolerance test
changes of the level at each time
Measured: preopertively, postoperatively, at 3 month, at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Insulin Dependent Diabetes MellitusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Inha University Hospital, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735253
- Sponsor's protocol ID
- inha 09-58
- Acronym
- T2DM
- Status last verified
- Nov 2012
- First submitted
- 24 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Surgery for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01735253
- Acronym / sponsor ID
- T2DM / inha 09-58
- Conditions
- Non Insulin Dependent Diabetes Mellitus
- Keywords
- metabolic surgery, gastric bypass, duodenojejunal bypass, type 2 DM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Nov 2012 (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.
Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese.
We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.
The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study.
We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.
We will compare the clinical factors at each time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric bypass, duodenojejunal bypass | Experimental | Procedure: laparoscopic roux en Y gastric bypass / open duodenojejunal bypass |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- type 2 diabetes
- HbA1C > 7.0%
- BMI 23 - 34 or BMI 21-22 with viceral obesity
- insulin use less than 10 years
- uncerstanding the risks, hypothesis, expecting effects
Key exclusion criteria (15 listed)
- type 1 diabetes
- C-peptide < 1.0ng/ml
- BMI < 21
- severe cardiovascular diseases or their history
- malignancy or history
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 |
|---|---|---|
| laparoscopic roux en Y gastric bypass / open duodenojejunal bypassroutine GBP with 80cm roux and biliopancreatic limb | Procedure or surgery | gastric bypass, duodenojejunal bypass |
Primary outcome
Hemoglobin A1C
Time frame: preoperatively, at 3month, at 12 month
change of the level
1 secondary outcome
oral glucose tolerance test
Time frame: preopertively, postoperatively, at 3 month, at 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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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?
A study testing laparoscopic roux en Y gastric bypass / open duodenojejunal bypass in people with Non Insulin Dependent Diabetes Mellitus, run by Inha University Hospital at 1 site in South Korea.
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 15 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: finished, as of the sponsor's last update on 28 Nov 2012. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hemoglobin A1C (time frame: preoperatively, at 3month, at 12 month). 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 28 Nov 2012.