Assessment of Endogenous Oxalate Synthesis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-10

Study Completion Date

2024-09-09

Brief Summary

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This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet.

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Detailed Description

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Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use low-oxalate controlled diet and intravenous infusion of the isotope tracer carbon 13 oxalate, timed with blood and urine collections, to determine the daily rate of endogenous oxalate synthesis in non-stone forming volunteers and in subjects with calcium oxalate kidney stones. A DXA scan will be used to assess body composition.

Conditions

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Healthy Kidney Stone Obesity

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Constant infusion of 13C2-oxalate

Subjects who have passed screening, will consume a low-oxalate, normal calcium controlled diet for 5 days total. On Days 3 and 4, subjects will collect two 24-hour urines. On Day 5, they will receive a carbon 13 oxalate infusion which will occur at a constant rate for 6 hours, in the fasted state, following a priming dose. Hourly urine and twice hourly blood samples will be collected during the 6 hours. Meals will be resumed at the end of the infusion and timed urine collections will take place at home until the next day. A DXA scan will be performed to assess body composition at another date.

Group Type EXPERIMENTAL

Low-oxalate controlled diet

Intervention Type DIETARY_SUPPLEMENT

Participants will consume a diet that is controlled in its contents of protein, carbohydrates, fat, calcium, oxalate, vitamin C and sodium for 5 days. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

Primed, continuous intravenous infusion of 13C2-oxalate

Intervention Type OTHER

Participants will receive a continuous intravenous administration of carbon-13 oxalate, a naturally occurring form of oxalate, over the course of several hours until steady-state is achieved, using an IV catheter, while remaining fasting.

Interventions

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Low-oxalate controlled diet

Participants will consume a diet that is controlled in its contents of protein, carbohydrates, fat, calcium, oxalate, vitamin C and sodium for 5 days. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.

Intervention Type DIETARY_SUPPLEMENT

Primed, continuous intravenous infusion of 13C2-oxalate

Participants will receive a continuous intravenous administration of carbon-13 oxalate, a naturally occurring form of oxalate, over the course of several hours until steady-state is achieved, using an IV catheter, while remaining fasting.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Mentally competent adults, able to read and comprehend the consent form
* Body Mass Index (BMI) between 18.5 and 50 kg/m2
* Acceptable 24 hour urine collections (judged on screening)
* good health as judged from a medical history, reported medications, and a complete blood metabolic profile
* with or without history of calcium oxalate kidney stones

Exclusion Criteria

* History of any hepatic, bowel, or endocrine disease or other condition that may influence the absorption, transport or urine excretion of ions
* Abnormal urine chemistries or blood metabolic profiles
* Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
* Pregnancy, intention to become pregnant in the near future, or lactation
* Aged lower than 18 or greater than 75 years
* BMI lower than18.5 or greater than 50 kg/m2

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes