Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/11/2011
Date assigned
15/11/2011
Last edited
27/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chih-Kun Huang

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Loop Duodeno-Jejunal Bypass with Sleeve Gastrectomy for type 2 diabetes mellitus in low BMI patients: early results

Acronym

LD-JB SG

Study hypothesis

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

Not provided at time of registration

Study design

Prospective study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/10/2011

Overall trial end date

30/09/2013

Reason abandoned

Eligibility

Participant 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%

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant 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

Recruitment start date

01/10/2011

Recruitment end date

30/09/2013

Locations

Countries of recruitment

Taiwan

Trial participating centre

1 E-Da Road
Kaohsiung
82445
Taiwan

Sponsor information

Organisation

E-Da Hospital (Taiwan)

Sponsor details

No.1 Yida Road
Jiaosu Village
Yanchao District
Kaohsiung
82445
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.edah-hospital.com/en/index.html

Funders

Funder type

Hospital/treatment centre

Funder name

E-Da Hospital (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes