Healthy, Kidney Stone, Obesity
Conditions
Keywords
Oxalate, Kidney stones, Urolithiasis, Nephrolithiasis, Urologic disease, Oxalate metabolism
Brief summary
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.
Detailed description
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.
Interventions
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.
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endogenous Oxalate Synthesis Rate | day 5 | Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Oxalate Excretion | day 3-4 | 24-hr urinary oxalate excretion (mg/day) after equilibration on the low-oxalate controlled diet, measured by ion chromatography coupled with mass spectrometry. |
| Urinary Creatinine Excretion | day 3-4 | 24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
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. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Constant Infusion of 13C2-oxalate |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants |
| Age, Continuous | 41 years STANDARD_DEVIATION 11 |
| Body mass index | 31 kg/m2 STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Endogenous Oxalate Synthesis Rate
Daily oxalate synthesis rate (mg/day) determined by the 13c2-oxalate infusion method
Time frame: day 5
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constant Infusion of 13C2-oxalate | Endogenous Oxalate Synthesis Rate | 17 mg/day | Standard Deviation 4 |
Urinary Creatinine Excretion
24-hr urinary creatinine excretion (g/day) after equilibration on the low-oxalate controlled diet.
Time frame: day 3-4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constant Infusion of 13C2-oxalate | Urinary Creatinine Excretion | 1.6 g/day | Standard Deviation 0.5 |
Urinary Oxalate Excretion
24-hr urinary oxalate excretion (mg/day) after equilibration on the low-oxalate controlled diet, measured by ion chromatography coupled with mass spectrometry.
Time frame: day 3-4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Constant Infusion of 13C2-oxalate | Urinary Oxalate Excretion | 20 mg/day | Standard Deviation 4 |