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

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status: Unknown

Conditions: Diabetes Mellitus; Obesity

Treatments: Procedure: Modified gastric bypass.; Procedure: Gastric bypass; Procedure: Slevee Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02310555

HCUVA-MSS-JL

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

Gastric bypass

Active Comparator group

Description:

classic Gastric bypass

Treatment:

Procedure: Gastric bypass

Modified gastric bypass.

Active Comparator group

Description:

Modified gastric bypass. Resection body and fundus gastric

Treatment:

Procedure: Modified gastric bypass.

Slevee Gastrectomy

Active Comparator group

Description:

Slevee Gastrectomy

Treatment:

Procedure: Slevee Gastrectomy