Morbid ObesitySADI-S 250NCT01463904
Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
An observational study of Morbid Obesity and Diabetes, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Diabetes
- What is being tested?
- SADI-S 250
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2007to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Morbid obesity patients and patients with obesity and T2DM
Who may be able to join
- BMI > 30 with T2DM or BMI > 40
Who cannot join
- Oncologic patients, alcoholic patients, mentally retarded
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Andrés Sánchez-Pernaute, MD PhD, +3413303184, asanchezp.hcsc@salud.madrid.org
Andrés Sánchez-Pernaute, MD PhD
About this study
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.
Read the detailed description
A sleeve gastrectomy over a wide bougie is performed. Then the proximal duodenum is divided and anastomosed to the ileum 250 cm from the cecum.
The preoperative studies and postoperative follow up is similar to those performed before and after other bariatric procedures.
- Conditions
- Morbid Obesity, Diabetes
- Being tested
- SADI-S 250
- Keywords
- Morbid obesity, duodenal switch, diabetes, decrease in cardiac risk, remission of T2DM
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SADI-S 250Procedure or surgery
Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Morbid obese, diabetics | Patients with morbid obesity or severe metabolic disease Receives: Procedure: SADI-S 250 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startApr 2007
- Primary completionJul 2009
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Sanchez-Pernaute, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463904
- Sponsor's protocol ID
- FMMA-08 Sánchez-Pernaute
- Acronym
- SADI-S 250
- Status last verified
- Oct 2011
- First submitted
- 31 Oct 2011
- Last updated
- 2 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
- ClinicalTrials.gov ID
- NCT01463904
- Acronym / sponsor ID
- SADI-S 250 / FMMA-08 Sánchez-Pernaute
- Conditions
- Morbid Obesity, Diabetes
- Keywords
- Morbid obesity, duodenal switch, diabetes, decrease in cardiac risk, remission of T2DM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A sleeve gastrectomy over a wide bougie is performed. Then the proximal duodenum is divided and anastomosed to the ileum 250 cm from the cecum.
The preoperative studies and postoperative follow up is similar to those performed before and after other bariatric procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Morbid obese, diabetics | – | Procedure: SADI-S 250Patients with morbid obesity or severe metabolic disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Morbid obesity patients and patients with obesity and T2DM
Key inclusion criteria (1 listed)
- BMI > 30 with T2DM or BMI > 40
Key exclusion criteria (1 listed)
- Oncologic patients, alcoholic patients, mentally retarded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SADI-S 250Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy | Procedure or surgery | Morbid obese, diabetics |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity and Diabetes, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2011; AzTrials last refreshed its copy on 8 Nov 2026.