Obesity Clinical Trial
Official title:
Nephrolithiasis and Bariatric Surgery
Verified date | March 2014 |
Source | Indiana Kidney Stone Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
Test the hypothesis that the new bariatric surgical procedures (BSP) increase stone risk, and will result in an increased incidence and prevalence of stone disease; the purpose is to determine if BSP patients require special management for stone prevention. This study does not include the bariatric surgery but enrolls subjects who are already scheduled for surgery with an affiliated surgeon. The study procedure is to collect 24 hour urines pre-and post surgically to evaluate the risk of kidney stone procedure after surgery.
Status | Completed |
Enrollment | 89 |
Est. completion date | December 2012 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Already scheduled to undergo bariatric surgery with a Clarian affiliated surgeon in Indianapolis, IN - Over the age of 18 - Able to give informed consent - Able to comply with 24 hour urine collections at specified times Exclusion Criteria: - Not scheduled for bariatric surgery - Bariatric surgery to be done by a non-Clarian affiliated surgeon - Unable to give informed consent - Unwilling/unable to comply with 24 hour urine collections at specified times |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Methodist Hospital | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana Kidney Stone Institute | Indiana University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To quantify the prevalence of stone disease among patients at the Clarian Hospitals who have had BSP between 3 and 3.5 years previously. | In the next two years | No | |
Secondary | To identify clinical and laboratory risk factors for incident nephrolithiasis following bariatric surgery. | In the next two years | No |
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