Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00456352
Protocol/serial number
AS07004
Study information
Scientific title
Acronym
Study hypothesis
Treatment success based on patients glycaemic control measured by achieving HbA1c level less than 7% as per the American Diabetes Association (ADA) recommendation.
Ethics approval
Approval received from the local ethics committee (Comite de Etica e Pesquisa do Hospital Sao Camilo) of the Ethics and Research National Committee of the Brazilian Government on the 14th March 2007.
Study design
Prospective, single arm, single centre, open label, non-randomised, uncontrolled study
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Type Two Diabetes Mellitus (T2DM)
Intervention
All patients will have the duodenal bypass surgery. The surgery should last anywhere from 40 minutes to one hour. The follow-up visits are scheduled for 2 weeks, 4 weeks, 3, 6, 9, and 12 months post surgery. We anticipate the study duration to be 18 to 24 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Treatment success, evaluated at 6 and 12 months, based on patients glycaemic control measured by achieving HbA1c level less than 7% as per the ADA recommendation.
Secondary outcome measures
1. Improvement in physiological measurements (glycaemic control, lipids) (success determined at 6 and 12 months)
2. Co-morbidity improvement, determined by comparing pre-operative co-morbidities to the status post-operatively (success determined at 12 months)
3. Improvement in Quality of Life using the 36-item Short Form (SF-36) questionnaire, determined by comparing pre-operative to post-operative quality of life (success determined at 12 months). We have licensed the SF-36 questionnaire from Quality Metrics and will utilise their guide for interpreting the data
Overall trial start date
11/04/2007
Overall trial end date
11/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age between 20 and 65 years old
2. Body Mass Index (BMI) between 23 and 34
3. Oral agents or insulin to control Type Two Diabetes Mellitus (T2DM)
4. Inadequate control of diabetes as defined as HbA1c greater than 7.5 mg/dl
5. Understanding of the mechanisms of action of the treatment
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 patients
Participant exclusion criteria
1. More than ten years of T2DM diagnosis
2. More than seven years of insulin use
3. Previous abdominal operations
4. Coagulopathy
5. Liver cirrhosis
6. Unable to comply with study requirements, follow-up schedule or give valid informed consent
7. Currently pregnant (pregnancy test required for confirmation for those of child bearing years)
Recruitment start date
11/04/2007
Recruitment end date
11/10/2008
Locations
Countries of recruitment
Brazil
Trial participating centre
Av. Pompeia 1178
Sao Paolo
SP CEP 05022-001
Brazil
Sponsor information
Organisation
US Surgical (USA)
Sponsor details
195 McDermott Avenue
North Haven
06473
United States of America
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
US Surgical (USA)
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