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Effect of Gastric Bypass on Patients With Type 2 Diabetes and/or Dyslipidemia

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ClinicalTrials.gov Identifier: NCT00879125
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : September 14, 2009
Information provided by:
Vanderbilt University

Brief Summary:
This is a retrospective review of patients who have undergone bariatric surgery at VUMC and who have type 2 Diabetes and/or dyslipidemia. The investigators have previously found that gastric bypass significantly improves diabetes 6-12 months after surgery. The investigators are interested in looking at the longer term results after surgery.

Condition or disease
Type 2 Diabetes

Detailed Description:

Review and record changes in the subject's medication. subjects vitals: weight, blood pressure, and fasting blood values, which include:

  • HbA1c
  • Fasting blood glucose
  • Fasting Insulin
  • Lipid Panel ( total cholesterol, LDL, HDL and triglycerides) were obtained.

Study Type : Observational
Actual Enrollment : 219 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Effect of Gastric Bypass on Type 2 Diabetes and/or Dyslipidemia
Study Start Date : November 1999
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. glycemic control [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Correction of lipid profiles [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 66 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Type 2 diabetes with a BMI over 35kg/m2

Inclusion Criteria:

Patients who have had diabetes and/or dyslipidemia prior to gastric by-pass. -

Exclusion Criteria:Patients who have had type 2 diabetes that was diet controlled at time of surgery; and debilitated patients who are unable to come in for a physical exam.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879125

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Principal Investigator: William O Richards, MD Vanderbilt University Medical Center

Responsible Party: Joan Kaiser, RN, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00879125     History of Changes
Other Study ID Numbers: 080368
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: September 14, 2009
Last Verified: September 2009

Keywords provided by Vanderbilt University:
Gastric by-pass on patients with T2DM

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