Duodenal exclusion for the treatment of type 2 diabetes mellitus
| ISRCTN | ISRCTN79580044 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79580044 |
| ClinicalTrials.gov number | NCT00456352 |
| Secondary identifying numbers | AS07004 |
- Submission date
- 11/04/2007
- Registration date
- 22/05/2007
- Last edited
- 07/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ricardo Cohen
Scientific
Scientific
Av. Pompeia 1178
Pompeia
Sao Paolo
SP CEP 05022-001
Brazil
Study information
| Study design | Prospective, single arm, single centre, open label, non-randomised, uncontrolled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Duodenal exclusion for the treatment of type 2 diabetes mellitus |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 11/04/2007 |
| Completion date | 11/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 patients |
| Key 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 |
| Key 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) |
| Date of first enrolment | 11/04/2007 |
| Date of final enrolment | 11/10/2008 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Av. Pompeia 1178
Sao Paolo
SP CEP 05022-001
Brazil
SP CEP 05022-001
Brazil
Sponsor information
US Surgical (USA)
Industry
Industry
195 McDermott Avenue
North Haven
06473
United States of America
| Website | http://www.ussurgical.com |
|---|---|
"ROR" |
https://ror.org/00grd1h17 |
Funders
Funder type
Industry
US Surgical (USA)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2012 | 07/02/2019 | Yes | No |
Editorial Notes
07/02/2019: Publication reference added.
