Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633811
Status:
RECRUITING
Last Update Posted:
2024-03-07
First Post:
2020-11-11
Brief Title:
Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone Formers
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Effect of Weight Loss on Urinary Oxalate Excretion in Obese Calcium Oxalate Kidney Stone
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This protocol seeks to determine if weight reduction with the Optifast VLCD program leads to reduced contribution of endogenous oxalate synthesis to the urinary oxalate pool in obese calcium oxalate stone formers
Detailed Description:
Obese adults 19 and 65 years with a history of calcium oxalate kidney stone disease will be recruited at both University of Alabama at Birmingham UAB and University of Texas South Western UTSW Following consent subjects will complete a screening phase which includes 1 a meeting with a dietitian to ensure willingness to consume controlled ultra-low oxalate diets and determine anthropometric measurements and blood pressure 2 collection of fasted blood and 2 x 24-hour urine specimens on self-choice diets to determine general health status and urinary chemistries respectively 3 completion of a 7-day run-in diet that includes the use of one serving of an Optifast meal daily to assess tolerance to Optifast VLCD products Participants will then consume an eucaloric ultra-low oxalate controlled diet for 6 days The controlled dietary phase involves 2 days of dietary equilibration followed by 2 x 24-hour urine collections and on the 5th day a dietary oxalatesucralose oral load Following the dietary oxalatesucralose oral load subjects will have blood collected every 30 minutes and collect 1-hour urines Participants will then go on an intensive 14-week Optifast VLCD Program to induce weight loss At the end of this Optifast VLCD Program participants will again perform the low oxalate controlled diet and dietarysucralose oral load study A total of 40 adult obese calcium oxalate kidney stone formers 20 male and 20 female will be enrolled 20 at UAB and 20 at UTSW
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