Condition category
Nutritional, Metabolic, Endocrine
Date applied
11/04/2007
Date assigned
22/05/2007
Last edited
22/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ricardo Cohen

ORCID ID

Contact details

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

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

http://www.ussurgical.com

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

Publication citations

Additional files

Editorial Notes