Trial record 1 of 42 for:    Open Studies | "Weight Reduction Programs"
Previous Study | Return to List | Next Study

Vascular Endothelium Changes After Bariatric Surgery (Endothelial Progenitor Cells) (EPC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of South Alabama
Sponsor:
Collaborator:
American Society for Metabolic and Bariatric Surgery
Information provided by (Responsible Party):
William Richards, University of South Alabama
ClinicalTrials.gov Identifier:
NCT01213940
First received: September 30, 2010
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: pre-bariatric weight loss program
Procedure: bariatric surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Vascular Endothelium Changes After Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • Change in plasma autoantibody levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Primary outcome is the change in plasma autoantibody levels (endothelial barrier function) 6 months after enrollment to surgery (LRYGB) or to standard medical therapy (SMT).


Estimated Enrollment: 70
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
baratric surgery
surgery vs.weight loss program 6 months prior to bariatric surgery
Procedure: bariatric surgery
bariatric surgery for weight loss
Other Name: bariatric surgery
pre-bariatric weight loss program
weight loss program prior to bariatric surgery
Behavioral: pre-bariatric weight loss program
standard 6 month physician directed pre-bariatric weight loss program
Other Name: weight loss program

Detailed Description:

Same as above

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213940

Locations
United States, Alabama
University of South Alabama Recruiting
Mobile, Alabama, United States, 36617
Contact: William O Richards, MD    251-471-7993    brichards@usouthal.edu   
Sponsors and Collaborators
University of South Alabama
American Society for Metabolic and Bariatric Surgery
Investigators
Principal Investigator: William O Richards, MD University of South Alabama, Department of Surgery
  More Information

No publications provided

Responsible Party: William Richards, Professor and Chairman of the Department of Surgery, University of South Alabama
ClinicalTrials.gov Identifier: NCT01213940     History of Changes
Other Study ID Numbers: 10-131
Study First Received: September 30, 2010
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014