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Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications (SADI-S 250)

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ClinicalTrials.gov Identifier: NCT01463904
Recruitment Status : Unknown
Verified October 2011 by Andres Sanchez-Pernaute, Hospital San Carlos, Madrid.
Recruitment status was:  Recruiting
First Posted : November 2, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Morbid Obesity Diabetes Procedure: SADI-S 250

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

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
Study Start Date : April 2007
Primary Completion Date : July 2009
Estimated Study Completion Date : April 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
Morbid obese, diabetics
Patients with morbid obesity or severe metabolic disease
Procedure: SADI-S 250
Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy


Outcome Measures

Biospecimen Retention:   Samples With DNA
Samples of subcutaneous and visceral fat, and samples of liver tissue.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Morbid obesity patients and patients with obesity and T2DM
Criteria

Inclusion Criteria:

  • BMI > 30 with T2DM or BMI > 40

Exclusion Criteria:

  • Oncologic patients, alcoholic patients, mentally retarded
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01463904


Locations
Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Andrés Sánchez-Pernaute, MD PhD    +3413303184    asanchezp.hcsc@salud.madrid.org   
Principal Investigator: Andrés Sánchez-Pernaute, MD PhD         
Sponsors and Collaborators
Hospital San Carlos, Madrid
More Information

Responsible Party: Andres Sanchez-Pernaute, MD, PhD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT01463904     History of Changes
Other Study ID Numbers: FMMA-08 Sánchez-Pernaute
First Posted: November 2, 2011    Key Record Dates
Last Update Posted: November 2, 2011
Last Verified: October 2011

Keywords provided by Andres Sanchez-Pernaute, Hospital San Carlos, Madrid:
Morbid obesity
duodenal switch
diabetes
decrease in cardiac risk
remission of T2DM

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms