Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
Conditions
Keywords
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
Brief summary
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
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.
Interventions
PROCEDURERoux-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.
Sponsors
Ethicon Endo-Surgery
University of Campinas, Brazil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Changes in body weight and fat distribution after intervention | 1 month, 2 months, 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 |
| Regression of carotid intima-media thickness | 1 month, 3 months, 6 months and 1 year |
Countries
Brazil
Outcome results
None listed