Heterozygous Individuals for AGXT and Kidney Stones
ConditionKidney Stone
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
pregnant individuals
individuals who are currently breast feeding
Trial design
Design model
Single group
Treatments tested in this trial
Controlled Diet
Other interventionParticipants will consume a controlled low oxalate diet for five days.
Glycolate Administration
Other interventionParticipants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Controlled Dietary StudyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Urinary Oxalate Excretion
Urinary oxalate excretion from urine samples will be measured as mg/day
Time frame
Baseline through Day 6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: