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New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I

NCT00566189 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2013-03-08

No results posted yet for this study

Summary

Bariatric surgery leads to remission of type 2 diabetes in morbid obese patients in 80% (Roux-en-Y gastric bypass)to 90% (biliopancreatic diversion and duodenal switch) of cases. The current consensus supports bariatric surgical treatment for diabetic patients with BMI as low as 35kg/m2 but it has questioned that lower body mass patients might benefit of the surgery as well.

This study is proposed to describe the effects of Roux-en-Y gastric bypass in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.

Conditions

Interventions

PROCEDURE

Roux-en-Y Bypass Gastroplasty

Under open laparotomy, a stomach section separates a 80-ml proximal gastric pouch. A jejunum section below Treitz's Angle creates an excluded gastrobiliopancreatic limb of 150cm. A Roux-in-Y retrocolic anastomosis of the alimentary limb promotes the continuity between the gastric pouch and the jejunum and a silastic ring reduces the pouch outlet.The anastomosis of the excluded limb is done 100cm below the silastic ring.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • University of Campinas, Brazil

    lead OTHER

Principal Investigators

  • José Carlos Pareja, MD, PhD · University of Campinas (UNICAMP)

  • Bruno Geloneze, MD, PhD · University of Campinas (UNICAMP)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2011-08-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00566189 on ClinicalTrials.gov