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

ISRCTN	ISRCTN56897851
DOI	https://doi.org/10.1186/ISRCTN56897851
Secondary identifying numbers	EMRP-099-084

Submission date: 06/10/2011
Registration date: 18/10/2011
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 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

Contact information

Prof Chih Kun Huang
Scientific

1 E-Da Road
Jian-Shu Tsuen
Yan-Chau Shiang
Kaohsiung
824
Taiwan

Email	dr.ckhuang@hotmail.com

Study information

Study design	Pilot 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 contact Professor Chih-Kun Huang at dr.ckhuang@hotmail.com to request a patient information sheet
Scientific title	Metabolic surgery for body mass index (BMI) < 27 kg/m2 patients with type 2 diabetes mellitus: early results
Study acronym	BMI
Study objectives	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(s)	The ethics committee and Institutional Review Board of the E-Da Hospital, 11 December 2008, ref: EMRP- 097-106
Health condition(s) or problem(s) studied	Type 2 diabetes Mellitus
Intervention	Surgery, Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)
Intervention type	Other
Primary outcome measure	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 study start date	01/06/2009
Completion date	31/05/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	21
Key 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%
Key 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
Date of first enrolment	01/06/2009
Date of final enrolment	31/05/2011

Locations

Countries of recruitment

Taiwan

Study participating centre

1 E-Da Road

Kaohsiung
824
Taiwan

Sponsor information

EDa Hospital (Taiwan)
Hospital/treatment centre

1 Yida Road
Jiaosu Village
Yanchao District
Kaohsiung
82445
Taiwan

Email	ed103221@edah.org.tw
Website	http://www.edah-hospital.com/en/index.html
"ROR"	https://ror.org/00eh7f421

Funders

Funder type

Hospital/treatment centre

EDa Hospital, Kaohsiung (Taiwan)

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