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 ]
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.