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

This study is currently recruiting participants.

Verified October 2011 by Hospital San Carlos, Madrid

Sponsor:

Information provided by (Responsible Party):

Andres Sanchez-Pernaute, Hospital San Carlos, Madrid

ClinicalTrials.gov Identifier:

NCT01463904

First received: October 31, 2011

Last updated: November 1, 2011

Last verified: October 2011

History of Changes

Purpose

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	Intervention
Morbid Obesity Diabetes	Procedure: SADI-S 250

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity

U.S. FDA Resources

Further study details as provided by Hospital San Carlos, Madrid:

Biospecimen Retention: Samples With DNA

Samples of subcutaneous and visceral fat, and samples of liver tissue.

Estimated Enrollment:	250
Study Start Date:	April 2007
Estimated Study Completion Date:	April 2015
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Morbid obese, diabetics Patients with morbid obesity or severe metabolic disease	Procedure: SADI-S 250 Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	October 31, 2011
Last Updated:	November 1, 2011
Health Authority:	Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital San Carlos, Madrid:

Morbid obesity
duodenal switch
diabetes
decrease in cardiac risk
remission of T2DM

Additional relevant MeSH terms:

Diabetes Mellitus
Obesity
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013

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