Ignite Creation Date:
2024-05-06 @ 12:37 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03808090
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2018-12-26
Brief Title:
Obesity and Endogenous Oxalate Synthesis
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Obesity and Endogenous Oxalate Synthesis
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Ingest fixed diets containing low amounts of oxalate for 4 days
Collect 24-hr urine samples during the fixed diet
The study will recruit adult participants without history of kidney stones Participants will
Ingest fixed diets containing low amounts of oxalate for 4 days
Collect 24-hr urine samples during the fixed diet
Detailed Description:
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 males30 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 mgday normal calcium 1000 mgday 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
Screening phase The study will enroll 60 individuals without history of kidney stones 30 males30 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 mgday normal calcium 1000 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K08DK115833-01A1 | NIH | None | httpsreporternihgovquickSearch1K08DK115833-01A1 |