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
  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 2
Phase 3

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

Resource links provided by NLM:


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 ]

Enrollment: 36
Study Start Date: August 2007
Study Completion Date: December 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Name: Roux-en-Y Gastric Bypass

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

Locations
Brazil
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, SP, Brazil
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: Bruno Geloneze, Prof Dr Bruno Geloneze, MD, PhD, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00566189     History of Changes
Other Study ID Numbers: LIMED0004
Study First Received: November 30, 2007
Last Updated: March 7, 2013
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

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Insulin Resistance
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

ClinicalTrials.gov processed this record on October 19, 2014