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

December 4, 2014 updated by: Juan Lujan, Hospital Universitario Virgen de la Arrixaca

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan A. Luján Mompean, Ph D; Section chief
  • Phone Number: 968369677

Study Contact Backup

  • Name: Pascual Parrilla Paricio, Ph D; Department head

Study Locations

  • Spain
    • Murcia
      • El Palmar., Murcia, Spain, 30120
        • Recruiting
        • Hospital Clinico Universitario Virgen de La Arrixaca
        • Contact:
          • Juan A. Luján, Ph D
          • Phone Number: 968369677
        • Principal Investigator:
          • Juan A. Luján, Ph D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
Procedure: Slevee Gastrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Durign two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight loss
Time Frame: During two years
During two years
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
During three months since surgery
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
Since third month after surgery untiil two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Virgen de la Arrixaca

Investigators

  • Principal Investigator: Juan A. Luján Mompean, Ph D; Section chief, Hospital Clinico Universitario Virgen Arrixaca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

November 26, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCUVA-MSS-JL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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