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
Protocol serial number	N/A
Sponsor	E-Da Hospital (Taiwan)
Funder	E-Da Hospital (Taiwan)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Chih-Kun Huang
Scientific

1 E-Da Road
Jian-Shu Tsuen
Yan-Chau Shiang
Kaohsiung
82445
Taiwan

Study information

Primary study design	Interventional
Study design	Prospective study
Secondary study design	Non randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	1. Resolution of co-morbidities 2. Complications related to procedure
Completion date	30/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	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

1 E-Da Road

Kaohsiung
82445
Taiwan

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes