Heterozygous Individuals for AGXT and Kidney Stones

Not Applicable

Not yet recruiting

• Conditions: Kidney Stone
• Interventions: Other: Controlled Diet; Other: Glycolate Administration

• Registration Number: NCT04430426
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

This study seeks to examine the effects of a heterozygous mutation of the AGXT gene in a stone forming population on endogenous oxalate production. Participants will consume a controlled low-oxalate diet and provide blood and urine samples to measure the amount of oxalate in their bodies. Subjects will then be administered an intravenous (IV) load of glycolate, providing additional blood and urine samples afterwards to measure any increase in oxalate levels.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03
• Study Start: 2025-07-01
• Primary Completion: 2026-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• at least 18 years of age
• history of calcium oxalate stones
• heterozygous mutation of the AGXT gene, as evidenced by results from the Invitae Nephrolithiasis Panel
• willingness to comply with a controlled diet for five days

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Exclusion Criteria

• pregnant individuals
• individuals who are currently breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Controlled Dietary Study	Controlled Diet	Participants will consume the controlled diet for five days and be administered an intravenous (IV) load of glycolate. Participants will provide urine and blood samples both before the glycolate load to establish baseline levels and after the glycolate load to measure oxalate levels afterwards.
Controlled Dietary Study	Glycolate Administration	Participants will consume the controlled diet for five days and be administered an intravenous (IV) load of glycolate. Participants will provide urine and blood samples both before the glycolate load to establish baseline levels and after the glycolate load to measure oxalate levels afterwards.

Primary Outcome Measures

Name	Time	Method
Urinary Oxalate Excretion	Baseline through Day 6	Urinary oxalate excretion from urine samples will be measured as mg/day