Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS)
MSS
Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity
1 other identifier
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Oct 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedDecember 8, 2014
December 1, 2014
7 months
November 26, 2014
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission diabetes mellitus type II
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.
Durign two years
Secondary Outcomes (3)
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
Study Arms (3)
Gastric bypass
ACTIVE COMPARATORclassic Gastric bypass
Modified gastric bypass.
ACTIVE COMPARATORModified gastric bypass. Resection body and fundus gastric
Slevee Gastrectomy
ACTIVE COMPARATORSlevee Gastrectomy
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan A. Luján Mompean, Ph D; Section chief
Hospital Clínico Universitario Virgen Arrixaca
Central Study Contacts
Pascual Parrilla Paricio, Ph D; Department head
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section chief
Study Record Dates
First Submitted
November 26, 2014
First Posted
December 8, 2014
Study Start
October 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2016
Last Updated
December 8, 2014
Record last verified: 2014-12