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

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ClinicalTrials.gov Identifier: NCT02310555
Recruitment Status : Unknown
Verified December 2014 by Juan Lujan, Hospital Universitario Virgen de la Arrixaca.
Recruitment status was:  Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
Sponsor:
Information provided by (Responsible Party):
Juan Lujan, 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).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Obesity Procedure: Gastric bypass Procedure: Modified gastric bypass. Procedure: Slevee Gastrectomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity
Study Start Date : October 2014
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Gastric bypass
classic Gastric bypass
Procedure: Gastric bypass
Active Comparator: Modified gastric bypass.
Modified gastric bypass. Resection body and fundus gastric
Procedure: Modified gastric bypass.
Active Comparator: Slevee Gastrectomy
Slevee Gastrectomy
Procedure: Slevee Gastrectomy



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Weight loss [ Time Frame: During two years ]
  2. Adverse effects in the short term [ Time Frame: 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

  3. Adverse effects in the long term [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310555


Contacts
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Contact: Juan A. Luján Mompean, Ph D; Section chief 968369677
Contact: Pascual Parrilla Paricio, Ph D; Department head

Locations
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Spain
Hospital Clínico Universitario Virgen de la Arrixaca Recruiting
El Palmar., Murcia, Spain, 30120
Contact: Juan A. Luján, Ph D    968369677      
Principal Investigator: Juan A. Luján, Ph D         
Sponsors and Collaborators
Hospital Universitario Virgen de la Arrixaca
Investigators
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Principal Investigator: Juan A. Luján Mompean, Ph D; Section chief Hospital Clínico Universitario Virgen Arrixaca
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Responsible Party: Juan Lujan, Section chief, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT02310555    
Other Study ID Numbers: HCUVA-MSS-JL
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014
Keywords provided by Juan Lujan, Hospital Universitario Virgen de la Arrixaca:
Metabolic surgery
Additional relevant MeSH terms:
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Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight