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

Primary Purpose

Diabetes Mellitus, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gastric bypass
Modified gastric bypass.
Slevee Gastrectomy
Sponsored by
Hospital Universitario Virgen de la Arrixaca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Metabolic surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital Clínico Universitario Virgen de la ArrixacaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Gastric bypass

Modified gastric bypass.

Slevee Gastrectomy

Arm Description

classic Gastric bypass

Modified gastric bypass. Resection body and fundus gastric

Slevee Gastrectomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Weight loss
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
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

Full Information

First Posted
November 26, 2014
Last Updated
December 4, 2014
Sponsor
Hospital Universitario Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT02310555
Brief Title
Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS)
Acronym
MSS
Official Title
Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Virgen de la Arrixaca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Obesity
Keywords
Metabolic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastric bypass
Arm Type
Active Comparator
Arm Description
classic Gastric bypass
Arm Title
Modified gastric bypass.
Arm Type
Active Comparator
Arm Description
Modified gastric bypass. Resection body and fundus gastric
Arm Title
Slevee Gastrectomy
Arm Type
Active Comparator
Arm Description
Slevee Gastrectomy
Intervention Type
Procedure
Intervention Name(s)
Gastric bypass
Intervention Type
Procedure
Intervention Name(s)
Modified gastric bypass.
Intervention Type
Procedure
Intervention Name(s)
Slevee Gastrectomy
Primary Outcome Measure Information:
Title
Remission diabetes mellitus type II
Description
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.
Time Frame
Durign two years
Secondary Outcome Measure Information:
Title
Weight loss
Time Frame
During two years
Title
Adverse effects in the short term
Description
We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification
Time Frame
During three months since surgery
Title
Adverse effects in the long term
Description
We'll measure the number of patients with postoperative complications and the the degree of severity of Clavien- Dindo Classification
Time Frame
Since third month after surgery untiil two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan A. Luján Mompean, Ph D; Section chief
Phone
968369677
First Name & Middle Initial & Last Name or Official Title & Degree
Pascual Parrilla Paricio, Ph D; Department head
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan A. Luján Mompean, Ph D; Section chief
Organizational Affiliation
Hospital Clínico Universitario Virgen Arrixaca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clínico Universitario Virgen de la Arrixaca
City
El Palmar.
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan A. Luján, Ph D
Phone
968369677
First Name & Middle Initial & Last Name & Degree
Juan A. Luján, Ph D

12. IPD Sharing Statement

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

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