Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Obesity
Obesity, Morbid
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 19, 2014