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

Not Applicable

• Conditions: Diabetes Mellitus; Obesity
• Interventions: Procedure: Modified gastric bypass.; Procedure: Gastric bypass; Procedure: Slevee Gastrectomy

• Registration Number: NCT02310555
• Lead Sponsor: Hospital Universitario Virgen de la Arrixaca

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-26
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-04
• Last Update Submitted: 2014-12-04
• Study First Posted: 2014-12-08
• Last Update Posted: 2014-12-08
• Primary Completion: 2015-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified gastric bypass.	Modified gastric bypass.	Modified gastric bypass. Resection body and fundus gastric
Gastric bypass	Gastric bypass	classic Gastric bypass
Slevee Gastrectomy	Slevee Gastrectomy	Slevee Gastrectomy

Primary Outcome Measures

Name	Time	Method
Remission diabetes mellitus type II	Durign two years	1. 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.; 2. Complete remission: Normal HbA1c (\<6%); basal glucose \<100 mg / dl (\<5.6 mmol / l); Absence of drug treatment; At least one year.; 3. Prolonged remission: At least 5 years of remission.; 4. Improvement: HbA1c \<7% with pharmacological treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 El Palmar., Murcia, Spain