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

Hospital Universitario Virgen de la Arrixaca1 site in 1 country90 target enrollmentOctober 2014

ConditionsDiabetes Mellitus Obesity

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Hospital Universitario Virgen de la Arrixaca
Enrollment: 90
Locations: 1
Primary Endpoint: Remission diabetes mellitus type II
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2014

End Date

May 2016

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Universitario Virgen de la Arrixaca

Responsible Party

Principal Investigator

Juan Lujan

Section chief

Hospital Universitario Virgen de la Arrixaca

Eligibility Criteria

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
•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.

Outcomes

Primary Outcomes

Remission diabetes mellitus type II

Time Frame: 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 Outcomes

Weight loss(During two years)
Adverse effects in the short term(During three months since surgery)
Adverse effects in the long term(Since third month after surgery untiil two years)