Status:
COMPLETED
A Translational Approach to Gitelman Syndrome
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Oregon Clinical and Translational Research Institute
Conditions:
Gitelman Syndrome
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This study will test the response to a single dose of thiazide diuretic as a diagnostic test for Gitelman syndrome. Individuals with hypokalemic alkalosis will be enrolled. After a baseline study, the...
Detailed Description
The purpose of this study is to test the hypothesis that Gitelman syndrome (GS) can be diagnosed using a simple clinical protocol. GS is an inherited kidney disease that usually shows up in patients a...
Eligibility Criteria
Inclusion
- Institutional Review Board (IRB) approved written Informed Consent and Health Insurance Portability and Accountability Act (HIPAA) Authorization as per national regulations, must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- Subject is between the ages of 21 and 60.
- Female subjects of child bearing potential must have a negative urine pregnancy test at the screening visit (Study Visit 1) and must agree to maintain effective birth control during the study.
- Subjects who are referred to Dr. Ellison for evaluation of normotensive hypokalemia of unknown etiology
Exclusion
- Subject has known allergy to thiazide or sulfonamide medications
- Subject is pregnant or lactating.
- Subject has major systemic illnesses that affect potassium regulation through pathology or pharmacologic treatment. This category includes:
- Hypertension
- Requiring regular pharmacological control
- History of blood pressure greater than 140mmHg systolic and 90mmHg diastolic
- Congestive heart failure
- Cirrhosis of the liver
- Subject has documented kidney disease resulting in anuria, proteinuria or abnormal urinalysis, or requiring dialysis for treatment.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00822107
Start Date
January 1 2009
End Date
September 1 2013
Last Update
April 5 2019
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239