Condition category
Nutritional, Metabolic, Endocrine
Date applied
06/10/2011
Date assigned
18/10/2011
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 Laparoscopic Roux-en-Y gastric Bypass (LRYGB) surgery in non obeseT2DM patients.

Who can participate?
Either male or female patients aged 18 - 65 years, with a Body Mass Index (BMI) of less than 27 kg/m2. Participants should also be diagnosed with T2DM for at least 6 months.

What does the study involve?
Laparoscopic Roux-en-Y gastric Bypass (LRYGB) surgery.

What are the possible benefits and risks of participating?
Patients may experience reduced symptoms of T2DM, however there is the risk that there maybe 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 June 2009 and ended in May 2011.

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

Prof Chih Kun Huang

ORCID ID

Contact details

1 E-Da Road
Jian-Shu Tsuen
Yan-Chau Shiang
Kaohsiung
824
Taiwan
dr.ckhuang@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMRP-099-084

Study information

Scientific title

Metabolic surgery for body mass index (BMI) < 27 kg/m2 patients with type 2 diabetes mellitus: early results

Acronym

BMI

Study hypothesis

To see the effect of Surgery Laparoscopic Roux-en-Y Gastric bypass (LRYGB) on type 2 diabetes mellitus (T2DM) status on patients with BMI < 27kg/m2

Ethics approval

The ethics committee and Institutional Review Board of the E-Da Hospital, 11 December 2008, ref: EMRP- 097-106

Study design

Pilot 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 contact Professor Chih-Kun Huang at dr.ckhuang@hotmail.com to request a patient information sheet

Condition

Type 2 diabetes Mellitus

Intervention

Surgery, Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Remission of T2DM, defined by HbA1c < 6.5% without oral hypoglycemic drugs or insulin
2. Glycemic control, defined as HbA1C of < 7 % despite no use of anti-diabetic medications
3. Improvement of 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. Failure of surgical procedure, defined as no significant improvement or worsened if a patient required an additional anti-diabetic meditation

Secondary outcome measures

1. Resolution of co-morbities
2. Complications related to procedure

Overall trial start date

01/06/2009

Overall trial end date

31/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-65 years
2. BMI < 27 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

21

Participant exclusion criteria

1. Patients younger than 18 or older than 65 years
2. Those planning pregnancy in next 2 years
3. Patients with type 1 diabetes mellitus (T1DM)
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

01/06/2009

Recruitment end date

31/05/2011

Locations

Countries of recruitment

Taiwan

Trial participating centre

1 E-Da Road
Kaohsiung
824
Taiwan

Sponsor information

Organisation

EDa Hospital (Taiwan)

Sponsor details

1 Yida Road
Jiaosu Village
Yanchao District
Kaohsiung
82445
Taiwan
ed103221@edah.org.tw

Sponsor type

Hospital/treatment centre

Website

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

Funders

Funder type

Hospital/treatment centre

Funder name

EDa Hospital, Kaohsiung (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