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

This study has been completed.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Bruno Geloneze, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT00566189
First received: November 30, 2007
Last updated: March 7, 2013
Last verified: March 2013

November 30, 2007
March 7, 2013
August 2007
August 2011   (final data collection date for primary outcome measure)
Improvement or reversal of type 2 diabetes mellitus [ Time Frame: 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00566189 on ClinicalTrials.gov Archive Site
  • Changes in body weight and fat distribution after intervention [ Time Frame: 1 month, 2 months, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
  • Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
  • Improvement of insulin sensitivity as measured by insulin tolerance test [ Time Frame: 1 month, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
  • Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines [ Time Frame: one month, 2 months, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
  • Regression of carotid intima-media thickness [ Time Frame: 1 month, 3 months, 6 months and 1 year ] [ Designated as safety issue: No ]
  • Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
  • Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
  • Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection [ Time Frame: 6 months, 1 year and 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
New Frontiers on Bariatric Surgical Procedures: Classical Bypass for Type-2 Diabetic Patients With Obesity Grade I
New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2

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.

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.

Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus, Type 2
  • Insulin Resistance
  • Obesity
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.
Other Name: Roux-en-Y Gastric Bypass
Experimental: 1
Roux-en-Y bypass gastroplasty
Intervention: Procedure: Roux-en-Y Bypass Gastroplasty

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
December 2012
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Obesity grade I (BMI 30-34,9)
  • Weight variance less than 5% in the last 3 months.
  • Previous diagnosis of diabetes type 2.
  • Insulin requirement, alone or along with oral agents
  • Capacity to understand the procedures of the study.
  • To agree voluntarily to participate of the study, signing an informed consent.

Exclusion Criteria:

  • Positive Anti-GAD antibodies
  • Laboratorial signal of probable failure of insulin production, i. e., seric peptide C lesser than 1 ng/mL.
  • History of hepatic disease like cirrhosis or chronic active hepatitis.
  • Kidney dysfunction (creatinine > 1,4 mg/dl in women and > 1,5 mg/dl in men).
  • Hepatic dysfunction: aspartate aminotransferase or alanine aminotransferase 3x above upper normal limit.
  • Recent history of neoplasia (< 5 years).
  • Use of oral or injectable corticosteroids for more than consecutive 14 days in the last three months.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00566189
LIMED0004
No
Bruno Geloneze, University of Campinas, Brazil
University of Campinas, Brazil
Ethicon Endo-Surgery
Principal Investigator: José Carlos Pareja, MD, PhD University of Campinas (UNICAMP)
Principal Investigator: Bruno Geloneze, MD, PhD University of Campinas (UNICAMP)
University of Campinas, Brazil
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP