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

This study is currently recruiting participants.
Verified by University of Campinas, Brazil, June 2008

Sponsors and Collaborators: University of Campinas, Brazil
Ethicon Endo-Surgery
Information provided by: University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00566189
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Insulin Resistance
Obesity
Procedure: Roux-en-Y Bypass Gastroplasty
Phase II
Phase III

MedlinePlus related topics:   Diabetes    Obesity    Weight Loss Surgery   

ChemIDplus related topics:   Insulin    Glucagon-like peptide 1    Glucagon    Ghrelin    Baysilon    Polydimethylsiloxane   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:   New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2

Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   40
Study Start Date:   August 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Roux-en-Y bypass gastroplasty
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.

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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: ALT and/or AST 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566189

Contacts
Contact: Bruno Geloneze, MD, PhD     +55-19-3521-8589     limedunicamp@gmail.com    

Locations
Brazil, SP
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)     Recruiting
      Campinas, SP, Brazil
      Contact: Brenno D Astiarraga, Biol.     +55-19-3521-8589     limedunicamp@gmail.com    
      Principal Investigator: Bruno Geloneze, MD, PhD            
      Principal Investigator: José Carlos Pareja, MD, PhD            
      Sub-Investigator: Sylka R Geloneze, MD            
      Sub-Investigator: Marcelo MO Lima, MD            
      Sub-Investigator: Brenno D Astiarraga, Biol.            
      Sub-Investigator: Carla Fiori, Nurse            
      Sub-Investigator: Elinton Chaim, MD, PhD            

Sponsors and Collaborators
University of Campinas, Brazil
Ethicon Endo-Surgery

Investigators
Principal Investigator:     José Carlos Pareja, MD, PhD     University of Campinas (UNICAMP)    
Principal Investigator:     Bruno Geloneze, MD, PhD     University of Campinas (UNICAMP)    
  More Information

Publications:

Responsible Party:   University of Campinas, Brazil ( Bruno Geloneze )
Study ID Numbers:   LIMED0004
First Received:   November 30, 2007
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00566189
Health Authority:   Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
diabetes mellitus, type 2  
Insulin resistance  
Intra-Abdominal Fat  
Omentum  
duodenal exclusion  
bariatric surgery  
Glucagon-Like Peptide 1  
Gastric Inhibitory Polypeptide
insulin
glucagon
ghrelin
adiponectin
Cytokines

Study placed in the following topic categories:
Obesity
Gastric Inhibitory Polypeptide
Metabolic Diseases
Glucagon
Diabetes Mellitus
Endocrine System Diseases
Overweight
Insulin
Glucagon-Like Peptide 1
Body Weight
Hyperinsulinism
Signs and Symptoms
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Insulin Resistance
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 29, 2008




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