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| ID | Type | Description | Link |
|---|---|---|---|
| 1K08DK115833-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The goal of this study is to determine if obesity is associated with increased endogenous oxalate synthesis as assessed by urinary oxalate excretion, which is a known risk factor for calcium oxalate kidney stones.
The study will recruit adult participants without history of kidney stones. Participants will
In this study the investigators propose to measure the excretion of urinary oxalate on a fixed diet with controlled amounts of oxalate, in individuals of varying body sizes without history of kidney stones. The 24-hr urinary oxalate excretion on such a low-oxalate normal calcium fixed diet is determined to be an appropriate surrogate for endogenous oxalate synthesis.
Screening phase. The study will enroll 60 individuals without history of kidney stones (30 males/30 females) at the University of Alabama at Birmingham (UAB).
Screening will include blood complete metabolic profile, 24-hr urine specimens collected at home on self-selected diets and anthropometric measurements.
Dietary phase Participants will ingest a low-oxalate (<60 mg/day), normal calcium (1000 mg/day) fixed diet for 4 consecutive days, collect three 24-hr urines after 1 day of dietary equilibration and have a fasted blood draw on day 5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Individuals | Experimental | Normal individuals: no prior history of kidney stones |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal Individuals | Dietary Supplement | Controlled Dietary phase: Low oxalate fixed diet 4 days of fixed normal calorie diet with low oxalate (< 60 mg/day), normal calcium (800-1200 mg/day) |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Oxalate Excretion | Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day) | 3 days on the fixed diet |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Glycolate Excretion | mean of three 24-hr urinary glycolate collected on the fixed diet (mg/day) | 3 days on fixed diet |
| Urinary Creatinine Excretion | mean of there 24hr urinary creatinine excretion on the fixed diet ( g/day) |
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Inclusion Criteria
Age 19-70 yrs Body Mass Index > 18.5 kg/m2 Normal fasting serum electrolytes on comprehensive metabolic profile Willing to ingest fixed diets
Exclusion Criteria
Chronic Kidney Disease, estimated glomerular filtration rate < 60 ml/mn/1.73m2 Primary hyperoxaluria Liver, endocrine or renal diseases or any other condition that may influence the absorption, transport or urinary excretion of ions, which will compromise the interpretation of results, including: Cystic fibrosis, Cystinuria, Uric acid stone former, Nephrotic syndrome, Sarcoidosis, Renal tubular acidosis, Primary hyperparathyroidism, Neurogenic bladder, Urinary diversion Pregnancy or breast-feeding Incompatible dietary requirements with the study, food allergies or intolerance to any of the foods in study menus Active malignancy or treatment for malignancy within 12 months prior to screening Utilization of immunosuppressive medication Uncontrolled Hypertension or diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Kyle D Wood, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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total study enrollment
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Individuals | Normal individuals: no prior history of kidney stones Normal Individuals: Controlled Dietary phase: Low oxalate fixed diet 4 days of fixed eucaloric diet with low oxalate (< 60 mg/day), normal calcium (800-1200 mg/day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Individuals | Normal individuals: no prior history of kidney stones Normal Individuals: Controlled Dietary phase: Low oxalate fixed diet 4 days of fixed eucaloric diet with low oxalate (< 60 mg/day), normal calcium (800-1200 mg/day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Oxalate Excretion | Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day) | Posted | Mean | Standard Deviation | mg/day | 3 days on the fixed diet |
|
|
7 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Individuals | Normal individuals: no prior history of kidney stones Normal Individuals: Controlled Dietary phase: Low oxalate fixed diet 4 days of fixed eucaloric diet with low oxalate (< 60 mg/day), normal calcium (800-1200 mg/day) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Kyle Wood | University of Alabama at Birmingham | 205-996-2295 | kylewood@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2024 | Jun 28, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 17, 2024 | Aug 8, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 3 days on the fixed diet |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
|
|
| Secondary | Urinary Glycolate Excretion | mean of three 24-hr urinary glycolate collected on the fixed diet (mg/day) | Posted | Mean | Standard Deviation | mg/day | 3 days on fixed diet |
|
|
|
| Secondary | Urinary Creatinine Excretion | mean of there 24hr urinary creatinine excretion on the fixed diet ( g/day) | Posted | Mean | Standard Error | g/day | 3 days on the fixed diet |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |