Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534985
Status:
COMPLETED
Last Update Posted:
2023-04-10
First Post:
2020-08-25
Brief Title:
Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Time Restricted Feeding in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2023-04
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 proposed research will determine the feasibility of a time restricted feeding interventiona fasting regimen that restricts eating to a feeding window 8 hrsday for 1 year in adults with autosomal dominant polycystic kidney disease ADPKD who are overweight or obese The study will provide valuable information on the intervention in terms of safety adherence acceptability and tolerability Last this pilot trial will provide initial insight into biological changes including abdominal adiposity changes in kidney growth and function and markers of biological pathways related to the intervention
Detailed Description:
Mounting evidence suggests that a metabolic defect exists in autosomal dominant polycystic kidney disease ADPKD which likely contributes to cystic epithelial proliferation and subsequent cyst growth There are notable overlapping features and pathways among metabolism obesity andor ADPKD The investigators recently reported that in the Halt Progression of Polycystic Kidney Disease HALT-PKD Study A that overweight and obesity are strong independent predictors of more rapid kidney growth Moving beyond body mass index the investigators have novel preliminary data using magnetic resonance images MRIs from a small number of participants from HALT-PKD Study A that abdominal adiposity is an independent predictor of kidney growth and kidney function decline Adipocytes do not simply act as a fat reservoir but are active endocrine organs that promote release of pro-inflammatory cytokines and produce adipokines Numerous signaling pathways promoted by adipocytes are also implicated in cystogenesis Periods of fasting may counter adiposity-mediated signaling pathways and slow ADPKD progression Mild-to-moderate food restriction profoundly slows cyst growth and maintains renal function in rodent models of ADPKD which are characterized by metabolic reprogramming favoring enhanced aerobic glycolysis Notably fasting promotes a shift from carbohydrate to fat metabolism which could suppress cyst growth The investigators are currently conducting an ongoing behavioral weight loss pilot trial based on either daily caloric restriction or intermittent fasting in adults with ADPKD who are overweightobese As an alternative to these approaches time-restricted feeding TRF is a novel fasting regimen that restricts eating to a feeding window typically 8-12 hrsday As isocaloric TRF reduces disease progression in a rodent model of ADPKD including kidney body weight and mammalian target of rapamycin mTOR activity it may be an alternative and easier to adhere to dietary strategy to slow ADPKD progression Specific Aim Determine the feasibility of TRF without energy intake restriction in adults with ADPKD and overweightobesity The study will determine adherence to TRF by assessing the percent of participants achieving the goal of eating within an 8-hour TRF window measured objectively with a photographic food record and verified with continuous glucose monitoring data The study will also further assess the safety acceptability and tolerability of TRF by evaluation of safety labs adverse events and quality of life measures as well as changes in abdominal adiposity and total kidney volume TKV by magnetic resonance imaging MRI and markers of biological pathways AMP-activated protein kinase AMPK mTOR insulin-like growth factor 1 IGF1
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