Trial Outcomes & Findings for Obesity and Endogenous Oxalate Synthesis (NCT NCT03808090)

NCT ID: NCT03808090

Last Updated: 2024-09-19

Results Overview

Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 58 participants
• Primary outcome timeframe: 3 days on the fixed diet
• Results posted on: 2024-09-19

Participant Flow

total study enrollment

Participant milestones

Measure	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)
Overall Study STARTED	58
Overall Study COMPLETED	58
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Obesity and Endogenous Oxalate Synthesis

Baseline characteristics by cohort

Measure	Normal Individuals n=58 Participants 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	28 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	58 Participants n=5 Participants
Body Mass Index	29 kg/m2 STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: 3 days on the fixed diet

Mean Urinary oxalate excretion from three 24 hour urine collections on the fixed diet (mg/day)

Outcome measures

Measure	Normal Individuals n=58 Participants 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)
Urinary Oxalate Excretion	24 mg/day Standard Deviation 10

SECONDARY outcome

Timeframe: 3 days on fixed diet

mean of three 24-hr urinary glycolate collected on the fixed diet (mg/day)

Outcome measures

Measure	Normal Individuals n=58 Participants 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)
Urinary Glycolate Excretion	32 mg/day Standard Deviation 14

SECONDARY outcome

Timeframe: 3 days on the fixed diet

mean of there 24hr urinary creatinine excretion on the fixed diet ( g/day)

Outcome measures

Measure	Normal Individuals n=58 Participants 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)
Urinary Creatinine Excretion	1.47 g/day Standard Error 0.58

Adverse Events

Normal Individuals

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Kyle Wood

University of Alabama at Birmingham

Phone: 205-996-2295

Email: kylewood@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place