NCT02310555UnknownNot Applicable
Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity
Hospital Universitario Virgen de la Arrixaca2 sites in 1 country90 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Remission diabetes mellitus type II
Study 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Investigators
Juan Lujan
Section chief
Hospital Universitario Virgen de la Arrixaca
Study Sites (2)
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