A Translational Approach to Gitelman Syndrome

NCT00822107 | Completed Results

• 1 other identifier: IRB00004529
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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, they will have the response to 50 mg hydrochlorothiazide on fractional chloride excretion examined.

Conditions

Gitelman Syndrome

Keywords

Hypokalemia; Bartter Syndrome; Salt Wasting

Outcome Measures

Primary Outcomes (1)

• Chloriuretic Response to a Thiaizde

  Change from baseline in fractional chloride excretion in response to a single dose of hydrochlorothiazide

  6 hours

Study Arms (1)

Thiazide Response

EXPERIMENTAL

Hydrochlorothiazide 50 mg will be administered by mouth once.

Drug: Hydrochlorothiazide

Interventions

Hydrochlorothiazide DRUG

50 mg one time

Also known as: HCTZ

Thiazide Response

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Oregon Clinical and Translational Research Institute: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Gitelman Syndrome; Hypokalemia; Bartter Syndrome

Interventions

Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperaldosteronism; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. David H. Ellison
• Organization: Oregon Health & Science University

ellisond@ohsu.edu

5034944465

Study Officials

• David H Ellison, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 14, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 5, 2019
• Results First Posted: April 5, 2019

Record last verified: 2019-04

Locations

US (1)