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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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New Frontiers on Bariatric Surgical Procedures. Classical Bypass for Type 2 Diabetic Patients With BMI Between 30 and 34.9 kg/m2

Conditions
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Diabetes Mellitus, Type 2, Insulin Resistance, Obesity

Intervention / Treatment
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* Procedure: Roux-en-Y Bypass Gastroplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Roux-en-Y bypass gastroplasty | Procedure: Roux-en-Y Bypass Gastroplasty<br>* 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.<br>* Other names: Roux-en-Y Gastric Bypass;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement or reversal of type 2 diabetes mellitus |  | 7 days, 14 days, 21 days, 1 month, 2 months, 3 months, six months and one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body weight and fat distribution after intervention |  | 1 month, 2 months, 3 months, 6 months and 1 year | 
| Changes in the secretion pattern of incretins, insulin and glucagon after intervention, as measured by standardized mixed meal tolerance test |  | 6 months and 1 year | 
| Improvement of insulin sensitivity as measured by insulin tolerance test |  | 1 month, 3 months, 6 months and 1 year | 
| Changes in seric free fatty acids, lipoproteins, adiponectin and other adipokines |  | one month, 2 months, 3 months, 6 months and 1 year | 
| Regression of carotid intima-media thickness |  | 1 month, 3 months, 6 months and 1 year | 
| Retardation of progression of disturbances of peripheral nerves as detected by electroneuromyography |  | 1 year and 2 years | 
| Retardation of progression of diabetic retinal complications as detected by fundoscopy and retinography |  | 1 year and 2 years | 
| Retardation of progression or regression of albuminuria as detected by microalbuminuria assay in 24-h urine collection |  | 6 months, 1 year and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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