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Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

Primary Purpose

Polycystic Kidney, Autosomal Dominant

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Polycystic Kidney, Autosomal Dominant focused on measuring Timed Feeding, Kidney Diseases, Body Weight

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Aged 18-65 years
  2. ADPKD diagnosis based on the modified Pei-Ravine criteria
  3. BMI 25-45 kg/m^2
  4. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate ≥30 mL/min/1.73 m^2
  5. Access to the internet with video chat capabilities and smartphone
  6. Typical eating duration >12 hrs/day
  7. Not currently participating in another interventional study or weight loss program
  8. Ability to provide informed consent

Exclusion Criteria:

  1. Diabetes mellitus (diagnosis or fasting glucose >126 mg/dL or Hemoglobin A1C >6.5%)
  2. Current nicotine use or history of use in the past 12 months
  3. Alcohol or substance abuse (self-report or undergoing treatment)
  4. History of hospitalization or major surgery within the last 3 months
  5. Untreated dyslipidemia (low density lipoprotein cholesterol > 190 mg/dL or triglycerides >400 mg/dL)
  6. Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg)
  7. Pregnancy, lactation, or unwillingness to use adequate birth control
  8. Cardiovascular disease, peripheral vascular disease, cerebrovascular disease, significant pulmonary or gastrointestinal disease (described below), cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis)
  9. Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active gallbladder disease
  10. Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants; study physician will be consulted as needed; antibiotics started during the intervention period are not an exclusion); regular use of obesity pharmacotherapeutic agents within the last 6 month
  11. History of clinically diagnosed eating disorder including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS)-2653 will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
  12. Weight loss >5% in past 3 months for any reason except post-partum weight loss; weight gain >5% in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study.
  13. Untreated hyper- or hyperthyroidism (TSH outside of normal range for laboratory or history of uncontrolled thyroid disorder). History of thyroid disorder or current thyroid disease treated with stable medication regimen for at least 6 months in acceptable.
  14. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on the Beck Depression Inventory will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study.
  15. History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary interventions.
  16. Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings

Sites / Locations

  • University of Colorado - Anschutz Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Time Restricted Feeding

Healthy Eating Advice without Time Restricted Feeding

Arm Description

Instructed to eat within an 8-hr window, beginning within 3 hrs of waking. In addition, provide current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.

Curriculum for the healthy eating control group will emphasize current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.

Outcomes

Primary Outcome Measures

Adherence
Percent adherence to the 8-hr TRF window (during the 7 day recordng period)
Feasibility to enroll participants
Numbers of individuals pre-screened and enrolled
Feasibility to retain participants
Numbers of individuals retained

Secondary Outcome Measures

Safety and tolerability, measured as adverse events
Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
Change in Body Weight
Body weight will be measured at baseline and monthly, using BodyTrace scales for remote, secure transmission of data.
Change in Abdominal adiposity
Abdominal adiposity will be quantified using MRI
Change in Body Composition
Body composition measured via dual-energy X-ray absorptiometry (DEXA)
Change in insulin-like growth factor binding protein-1 levels
Fasting serum insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Change in serum insulin-like growth factor-1 levels
Fasting serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Change in peripheral blood mononuclear cell (PBMC) AMPK expression
Peripheral blood mononuclear cell protein expression of AMP-activated kinase (AMPK) in each group
Change in PBMC S6K expression
Peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group
Change in β-hydroxybutyrate levels
Serum β-hydroxybutyrate levels in each group
Change in total kidney volume by magnetic resonance imaging (MRI)
Change in total kidney volume by MRI in each group
Change in quality of life
Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score
Change in mood
Mood state will be assessed with the Profile of Mood States 2 (POMS-2)
Change in pain
Modified version of the Wisconsin Brief Pain Survey

Full Information

First Posted
August 25, 2020
Last Updated
April 7, 2023
Sponsor
University of Colorado, Denver
Collaborators
PKD Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04534985
Brief Title
Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease
Official Title
Time Restricted Feeding in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 9, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
PKD Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The proposed research will determine the feasibility of a time restricted feeding intervention,a fasting regimen that restricts eating to a feeding window (8 hrs/day) 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, and/or 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 overweight/obese. 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 hrs/day). 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 overweight/obesity. 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]).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Kidney, Autosomal Dominant
Keywords
Timed Feeding, Kidney Diseases, Body Weight

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Time Restricted Feeding
Arm Type
Experimental
Arm Description
Instructed to eat within an 8-hr window, beginning within 3 hrs of waking. In addition, provide current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.
Arm Title
Healthy Eating Advice without Time Restricted Feeding
Arm Type
Active Comparator
Arm Description
Curriculum for the healthy eating control group will emphasize current clinical recommendations for the management of ADPKD, as well as chronic kidney disease, including moderate dietary sodium restriction (2.3-3 g), appropriate hydration, protein intake of 0.8/1.0 g/kg ideal body weight, moderate daily phosphate restriction (800 mg), and moderation in caloric intake.
Intervention Type
Behavioral
Intervention Name(s)
Dietary
Intervention Description
Dietary intake behavioral intervention via time restricted feeding and normal healthy eating recommendations vs. normal healthy eating recommendations without restricted
Primary Outcome Measure Information:
Title
Adherence
Description
Percent adherence to the 8-hr TRF window (during the 7 day recordng period)
Time Frame
1 year
Title
Feasibility to enroll participants
Description
Numbers of individuals pre-screened and enrolled
Time Frame
Through study enrollment, an expected duration of 12 months
Title
Feasibility to retain participants
Description
Numbers of individuals retained
Time Frame
Through study completion, an expected duration of 24 months
Secondary Outcome Measure Information:
Title
Safety and tolerability, measured as adverse events
Description
Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
Time Frame
Through study completion, an expected duration of 24 months
Title
Change in Body Weight
Description
Body weight will be measured at baseline and monthly, using BodyTrace scales for remote, secure transmission of data.
Time Frame
1 year
Title
Change in Abdominal adiposity
Description
Abdominal adiposity will be quantified using MRI
Time Frame
1 year
Title
Change in Body Composition
Description
Body composition measured via dual-energy X-ray absorptiometry (DEXA)
Time Frame
1 year
Title
Change in insulin-like growth factor binding protein-1 levels
Description
Fasting serum insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
Time Frame
1 year
Title
Change in serum insulin-like growth factor-1 levels
Description
Fasting serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
Time Frame
1 year
Title
Change in peripheral blood mononuclear cell (PBMC) AMPK expression
Description
Peripheral blood mononuclear cell protein expression of AMP-activated kinase (AMPK) in each group
Time Frame
1 year
Title
Change in PBMC S6K expression
Description
Peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group
Time Frame
1 year
Title
Change in β-hydroxybutyrate levels
Description
Serum β-hydroxybutyrate levels in each group
Time Frame
1 year
Title
Change in total kidney volume by magnetic resonance imaging (MRI)
Description
Change in total kidney volume by MRI in each group
Time Frame
1 year
Title
Change in quality of life
Description
Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score
Time Frame
1 year
Title
Change in mood
Description
Mood state will be assessed with the Profile of Mood States 2 (POMS-2)
Time Frame
1 year
Title
Change in pain
Description
Modified version of the Wisconsin Brief Pain Survey
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Change in resting energy expenditure
Description
Standard indirect calorimetry
Time Frame
1 year
Title
Change in energy intake
Description
24-hr dietary recalls will be analyzed using a random day in the 7-day photographic food record/continuous glucose monitoring collection period to evaluate self-reported energy intake
Time Frame
1 year
Title
Change in macronutrient intake
Description
24-hr dietary recalls will be analyzed using a random day in the 7-day photographic food record/CGM collection period to evaluate self-reported energy intake
Time Frame
1 year
Title
Change in self-reported physical activity
Description
Self-reported physical activity will be quantified using the Stanford Physical Activity Questionnaire
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 years ADPKD diagnosis based on the modified Pei-Ravine criteria BMI 25-45 kg/m^2 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated glomerular filtration rate ≥30 mL/min/1.73 m^2 Access to the internet with video chat capabilities and smartphone Typical eating duration >12 hrs/day Not currently participating in another interventional study or weight loss program Ability to provide informed consent Exclusion Criteria: Diabetes mellitus (diagnosis or fasting glucose >126 mg/dL or Hemoglobin A1C >6.5%) Current nicotine use or history of use in the past 12 months Alcohol or substance abuse (self-report or undergoing treatment) History of hospitalization or major surgery within the last 3 months Untreated dyslipidemia (low density lipoprotein cholesterol > 190 mg/dL or triglycerides >400 mg/dL) Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg) Pregnancy, lactation, or unwillingness to use adequate birth control Cardiovascular disease, peripheral vascular disease, cerebrovascular disease, significant pulmonary or gastrointestinal disease (described below), cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis) Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active gallbladder disease Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants; study physician will be consulted as needed; antibiotics started during the intervention period are not an exclusion); regular use of obesity pharmacotherapeutic agents within the last 6 month History of clinically diagnosed eating disorder including anorexia nervosa, bulimia, binge eating disorder. Score >20 on the Eating Attitudes Test (EATS)-2653 will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. Weight loss >5% in past 3 months for any reason except post-partum weight loss; weight gain >5% in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study. Untreated hyper- or hyperthyroidism (TSH outside of normal range for laboratory or history of uncontrolled thyroid disorder). History of thyroid disorder or current thyroid disease treated with stable medication regimen for at least 6 months in acceptable. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score > 18 on the Beck Depression Inventory will require further assessment by the Study MD to determine if it is appropriate for the subject to participate in the study. History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary interventions. Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen Nowak
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. data use agreement) are prerequisites to the sharing of data with the requesting party.
IPD Sharing Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
IPD Sharing Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Learn more about this trial

Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

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