Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06496542
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-07-03
Brief Title:
Renal Oxygen Consumption Insulin Sensitivity and Daily Caloric Restriction in ADPKD
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Renal Oxygen Consumption Insulin Sensitivity and Daily Caloric Restriction in Autosomal Dominant Polycystic Kidney Disease EXPLORE Study
Status:
RECRUITING
Status Verified Date:
2024-07
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:
EXPLORE
Brief Summary:
The proposed research is a pilot study assessing kidney oxidative metabolism and insulin sensitivity after a 2-year weight loss intervention in those with autosomal dominant polycystic kidney disease who are overweight or obese
Detailed Description:
Autosomal dominant polycystic kidney disease ADPKD is the most commonly inherited progressive kidney disease Overweight and obese phenotypes have been associated with disease progression in early-stage ADPKD Daily caloric restriction DCR 34 restriction per day from baseline weight maintenance requirements may aid in weight loss and ultimately slow ADPKD disease progression Weight loss via DCR may cause alterations in kidney oxidative metabolism and insulin sensitivity that can affect ADPKD disease progression This study aims to assess kidney oxidative metabolism via 11C-acetate PET scan protocol and insulin sensitivity via hyperinsulinemic-euglycemic clamp by leveraging an ongoing R01-funded trial NCT04907799 in DCR n10 vs control n10 groups at baseline BSL and 2 years The study will utilize the clinical outcome measures performed in the parent trial to address the subsequent novel aims Aim 1 Compare kidney oxidative metabolism and insulin sensitivity at BSL and 2 years in adults with ADPKD Aim 2 Define the relations among changes in kidney oxidative metabolism insulin sensitivity total kidney volume and weight over 2 years Currently it is unknown if weight loss via DCR modifies renal energy expenditure and substrate utilization
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 |
|---|---|---|---|
| P30DK048520 | NIH | None | None |