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

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00879125
First received: April 8, 2009
Last updated: September 10, 2009
Last verified: September 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • glycemic control [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correction of lipid profiles [ Time Frame: one year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   17 Years to 66 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Joan Kaiser, RN, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00879125     History of Changes
Other Study ID Numbers: 080368
Study First Received: April 8, 2009
Last Updated: September 10, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013