Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS)

Study Overview
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Brief Summary
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The aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI> 30).

Official Title
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Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity

Conditions
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Diabetes Mellitus, Obesity

Intervention / Treatment
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* Procedure: Gastric bypass
* Procedure: Modified gastric bypass.
* Procedure: Slevee Gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 30-40 Diabetes Mellitus type II less than 10 years of evolution. Anti-GAD, anti-pancreatic islets negative antibodies. C peptide normally between 0.9 and 4. Glycosylated hemoglobin greater than 6.5%. Less than 5 years of use insulin. Exclusion Criteria: Cirrosis hepática. coagulopathies. Type 1 diabetes. HIV positive. Stomach or small intestine previous surgeries . Diseases of the exocrine pancreas: pancreatitis, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis. Endocrinopathies: acromegaly, glucagonoma, Cushing's syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldosteronoma. Genetic syndromes with diabetes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gastric bypass<br>classic Gastric bypass | Procedure: Gastric bypass<br> <br> |
| Active Comparator: Modified gastric bypass.<br>Modified gastric bypass. Resection body and fundus gastric | Procedure: Modified gastric bypass.<br> <br> |
| Active Comparator: Slevee Gastrectomy<br>Slevee Gastrectomy | Procedure: Slevee Gastrectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission diabetes mellitus type II | Partial remission: Not diagnostic of DM HbA1c (<6.5%); Basal glucose 100-125 mg / dl (5.6-6.9 mmol / l); Absence of drug treatment; At least one year. Complete remission: Normal HbA1c (<6%); basal glucose <100 mg / dl (<5.6 mmol / l); Absence of drug treatment; At least one year. Prolonged remission: At least 5 years of remission. Improvement: HbA1c <7% with pharmacological treatment. | Durign two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | During two years | 
| Adverse effects in the short term | We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification | During three months since surgery | 
| Adverse effects in the long term | We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification | Since third month after surgery untiil two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolic surgery