Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells)

NCT ID: NCT01213940

Last Updated: 2024-05-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-05-31

Brief Summary

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Improvement in cardiovascular mortality is related to changes in pathologic autoantibodies and in the number of circulating functional replicative competent endothelial progenitor cells (EPC's) after bariatric surgery.

Detailed Description

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Same as above

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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baratric surgery

surgery vs.weight loss program 6 months prior to bariatric surgery

Group Type OTHER

bariatric surgery

Intervention Type PROCEDURE

bariatric surgery for weight loss

pre-bariatric weight loss program

weight loss program prior to bariatric surgery

Group Type OTHER

pre-bariatric weight loss program

Intervention Type BEHAVIORAL

standard 6 month physician directed pre-bariatric weight loss program

Interventions

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pre-bariatric weight loss program

standard 6 month physician directed pre-bariatric weight loss program

Intervention Type BEHAVIORAL

bariatric surgery

bariatric surgery for weight loss

Intervention Type PROCEDURE

Other Intervention Names

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weight loss program

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes, Glucose \> 200mg/dl, currently be ing treated with oral medications and HGA1c . 6.5, and BMI .35.

Exclusion Criteria

* Type 1 Diabetes
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Society for Metabolic and Bariatric Surgery

OTHER

Sponsor Role collaborator

University of South Alabama

OTHER

Sponsor Role lead

Responsible Party

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William Richards

Professor and Chairman of the Department of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William O Richards, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Alabama, Department of Surgery

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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10-131

Identifier Type: -

Identifier Source: org_study_id

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