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NCT00879125 Clinical Trial

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

Type 2 Diabetes Clinical Trial

Official title:
Effect of Gastric Bypass on Type 2 Diabetes and/or Dyslipidemia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00879125
Other study ID # 080368
Secondary ID
Status Completed
Phase N/A
First received April 8, 2009
Last updated September 10, 2009
Start date November 1999
Est. completion date November 2007

Study information
Verified date September 2009
Source Vanderbilt University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 219
Est. completion date November 2007
Est. primary completion date November 2007
Accepts healthy volunteers No
Gender Both
Age group 17 Years to 66 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary glycemic control one year No
Secondary Correction of lipid profiles one year No
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