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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00879125
First Posted: April 9, 2009
Last Update Posted: September 14, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Vanderbilt University
  Purpose
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
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Effect of Gastric Bypass on Type 2 Diabetes and/or Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

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

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

Enrollment: 219
Study Start Date: November 1999
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

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
Criteria

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.

  Contacts and Locations
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


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

Responsible Party: Joan Kaiser, RN, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00879125     History of Changes
Other Study ID Numbers: 080368
First Submitted: April 8, 2009
First Posted: April 9, 2009
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
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders