Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
SADI-S 250
1 other identifier
observational
250
1 country
1
Brief Summary
Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified duodenal switch. It is performed on morbid obese patients and severe T2DM patients with obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a remission of T2DM. A lower complication rate than for duodenal switch is expected.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 2, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedNovember 2, 2011
October 1, 2011
2.3 years
October 31, 2011
November 1, 2011
Conditions
Keywords
Study Arms (1)
Morbid obese, diabetics
Patients with morbid obesity or severe metabolic disease
Interventions
Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy
Eligibility Criteria
Morbid obesity patients and patients with obesity and T2DM
You may qualify if:
- BMI \> 30 with T2DM or BMI \> 40
You may not qualify if:
- Oncologic patients, alcoholic patients, mentally retarded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico San Carlos
Madrid, Madrid, 28040, Spain
Biospecimen
Samples of subcutaneous and visceral fat, and samples of liver tissue.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 2, 2011
Study Start
April 1, 2007
Primary Completion
July 1, 2009
Study Completion
April 1, 2015
Last Updated
November 2, 2011
Record last verified: 2011-10