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 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 trial start date
01/06/2009
Overall trial end date
31/05/2011
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list