Duodenal exclusion for the treatment of type 2 diabetes mellitus

ISRCTN	ISRCTN79580044
DOI	https://doi.org/10.1186/ISRCTN79580044
ClinicalTrials.gov (NCT)	NCT00456352
Protocol serial number	AS07004
Sponsor	US Surgical (USA)
Funder	US Surgical (USA)

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

Av. Pompeia 1178
Pompeia
Sao Paolo
SP CEP 05022-001
Brazil

Study information

Primary study design	Interventional
Study design	Prospective, single arm, single centre, open label, non-randomised, uncontrolled study
Secondary study design	Non randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	11/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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.