LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, São Paulo, Brazil
NCT Number: NCT00566189
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2 / Phase 3
Campinas, São Paulo, Brazil
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; most of the remainder achieve better glycemic control, even if they regain weight. 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.
Actually, many clinical researchers worldwide would consider a lower limit BMI of 30kg/m2, i.e., any grade of obesity.
This study is proposed to describe the effects of Roux-en-Y gastric bypass (Fobi-Capella technique, adapted to create a larger gastric pouch, about 80ml)in mild obese (BMI 30-35) human volunteers on incretins, insulin production and sensitivity and its clinical (diabetic chronic complications) and metabolic impact.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Roux-en-Y Gastric Bypass
Time frame: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year.
Time frame: 1 month, 2 months, 3 months, 6 months and 1 year
Time frame: 6 months and 1 year
Time frame: 1 month, 3 months, 6 months and 1 year
Time frame: one month, 2 months, 3 months, 6 months and 1 year
Time frame: 1 month, 3 months, 6 months and 1 year
Time frame: 1 year and 2 years
Time frame: 1 year and 2 years
Time frame: 6 months, 1 year and 2 years
University of Campinas, Brazil
Other
New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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