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

Obesity Clinical Trial

— MSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02310555
• Other study ID #: HCUVA-MSS-JL
• Status: Recruiting
• Phase: N/A
• First received: November 26, 2014
• Last updated: December 4, 2014
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: December 2014
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: Juan A. Luján Mompean, Ph D; Section chief
• Phone: 968369677
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

Procedure:
• Gastric bypass

• Modified gastric bypass.

• Slevee Gastrectomy

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario Virgen de la Arrixaca	El Palmar.	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Weight loss		During two years	Yes
Secondary	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	Yes
Secondary	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	Yes