Loop Duodeno-Jejunal Bypass with Sleeve Gastrectomy for type 2 diabetes mellitus in low BMI patients
| ISRCTN | ISRCTN63241920 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63241920 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/11/2011
- Registration date
- 15/11/2011
- Last edited
- 27/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims:
Type 2 diabetes mellitus (T2DM) is a disease with high mortality rates. It is the most common endocrine disorder worldwide. People with diabetes are at increased risk of cardiovascular diseases. The current treatment includes diet control, exercise, and use of anti-diabetic meditations. However, recent evidence suggests surgery can reduce the symptoms of T2DM, especially in morbidly obese patients. The aim of our study is to evaluate the effectiveness and safety of Loop Duodeno-Jejunal Bypass surgery in T2DM patients.
Who can participate?
Either male or female patients aged 18 - 65 years, with a Body Mass Index (BMI) of less than 35 kg/m2. Participants should also ahve been diagnosed with T2DM for at least 6 months.
What does the study involve?
Loop Duodeno-Jejunal Bypass surgery.
What are the possible benefits and risks of participating?
Patients may experience reduced symptoms of T2DM, however there is the risk that there may be complications from the surgery.
Where is the study run from?
EDa Hospital, Taiwan
When is the study starting and how long is it expected to run for?
The study started in October 2011 and will end in September 2013.
Who is funding the study?
EDa Hospital, Taiwan
Who is the main contact?
Professor Chih-Kun Huang
dr.ckhuang@hotmail.com
Contact information
Scientific
1 E-Da Road
Jian-Shu Tsuen
Yan-Chau Shiang
Kaohsiung
82445
Taiwan
Study information
| Study design | Prospective study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Loop Duodeno-Jejunal Bypass with Sleeve Gastrectomy for type 2 diabetes mellitus in low BMI patients: early results |
| Study acronym | LD-JB SG |
| Study objectives | To study the safety and efficacy of Loop Duodeno-Jejunal Bypass with sleeve gastrectomy for type 2 diabetes mellitus (T2DM) in low body mass index (BMI) patients |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Type 2 diabetes mellitus |
| Intervention | Surgery: Loop Duodeno-jejunal bypass with sleeve gastrectomy. There is only one study arm which is surgery: Loop duodeno-jejunal bypass with sleeve gastrectomy which will be done for consenting patients who fulfill the inclusion criteria. |
| Intervention type | Other |
| Primary outcome measure | Patients will be divided into four groups on the basis of their postsurgical status: 1. Those in remission of T2DM, defined by HbA1c < 6.5% without oral hypoglycemic drugs or insulin 2. Those with glycemic control, defined as HbA1C of < 7 % despite no use of anti-diabetic medications 3. Those with improvement of their T2DM, defined as a reduction of at least 25% in the fasting plasma glucose level and/ or at least 1% in the pre-operative HbA1c level with hypoglycemic drug treatment 4. Those with failure of surgical procedure, defined as no significant improvement or worsened if a patient required an additional anti-diabetic medication |
| Secondary outcome measures | 1. Resolution of co-morbidities 2. Complications related to procedure |
| Overall study start date | 01/10/2011 |
| Completion date | 30/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key inclusion criteria | 1. Age 18-65 years 2. BMI < 35 kg/m2 3. Poorly controlled T2DM for at least 6 months with glycosylated haemoglobin (Hb A1C) level of >7.0% |
| Key exclusion criteria | 1. Patients younger than 18 or older than 65 years 2. Those planning pregnancy in the next 2 years 3. Type 1 diabetes mellitus (T1DM) patients 4. Latent autoimmune diabetes in adults 5. Malignancy 6. Debilitating disease 7. Unresolved psychiatric illness 8. Substance abuse 9. American Society of Anesthesiologists (ASA) classification > III |
| Date of first enrolment | 01/10/2011 |
| Date of final enrolment | 30/09/2013 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
82445
Taiwan
Sponsor information
Hospital/treatment centre
No.1 Yida Road
Jiaosu Village
Yanchao District
Kaohsiung
82445
Taiwan
| Website | http://www.edah-hospital.com/en/index.html |
|---|---|
"ROR" |
https://ror.org/00eh7f421 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
