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

NCT ID: NCT02310555

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetes Mellitus Obesity

Keywords

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Metabolic surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Gastric bypass

classic Gastric bypass

Group Type ACTIVE_COMPARATOR

Gastric bypass

Intervention Type PROCEDURE

Modified gastric bypass.

Modified gastric bypass. Resection body and fundus gastric

Group Type ACTIVE_COMPARATOR

Modified gastric bypass.

Intervention Type PROCEDURE

Slevee Gastrectomy

Slevee Gastrectomy

Group Type ACTIVE_COMPARATOR

Slevee Gastrectomy

Intervention Type PROCEDURE

Interventions

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Gastric bypass

Intervention Type PROCEDURE

Modified gastric bypass.

Intervention Type PROCEDURE

Slevee Gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Responsible Party

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Juan Lujan

Section chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan A. Luján Mompean, Ph D; Section chief

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Virgen Arrixaca

Locations

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Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan A. Luján Mompean, Ph D; Section chief

Role: CONTACT

Phone: 968369677

Pascual Parrilla Paricio, Ph D; Department head

Role: CONTACT

Facility Contacts

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Juan A. Luján, Ph D

Role: primary

Other Identifiers

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HCUVA-MSS-JL

Identifier Type: -

Identifier Source: org_study_id