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Caloric Restriction for Polycystic Kidney Disease
N/A
Recruiting
Led By Kristen Nowak, PhD, MPH
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18-65 years of age
Total kidney volume (htTKV) > 600 mL, calculated from a previous kidney ultrasound or magnetic resonance imaging performed within the last 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-, 6-, 12-, and 24-months
Awards & highlights
Study Summary
This trial will determine whether a weight loss intervention can slow kidney growth in adults with a certain kidney disease.
Who is the study for?
Adults aged 18-65 with autosomal dominant polycystic kidney disease (ADPKD), overweight or obese, and not currently in weight loss programs can join. They must have internet for video chats, no recent smoking or major surgeries, and their kidneys should be functioning above a certain level.Check my eligibility
What is being tested?
The trial is testing if eating fewer calories each day helps slow down kidney growth in overweight ADPKD patients compared to standard advice. It includes checking belly fat by MRI and analyzing blood and fat samples for biological changes.See study design
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to dietary changes such as fatigue, hunger, mood swings, or digestive discomfort due to caloric restriction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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My kidneys are larger than normal, as shown by a recent scan.
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My BMI is between 25 and 45.
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I won't travel for more than 2 weeks without internet for the next year.
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My kidney function is at a safe level for the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 1-, 6-, 12-, and 24-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1-, 6-, 12-, and 24-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in height-Adjusted Total kidney volume
Secondary outcome measures
Change in C-reactive protein (circulating)
Change in abdominal adiposity
Change in adiponectin (adipose tissue)
+13 moreOther outcome measures
Adherence
Change in dietary Energy Intake
Change in free-living physical activity
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Standard Advice ControlExperimental Treatment1 Intervention
The standard advice control group will receive an initial consultation with a registered dietician regarding current clinical recommendations for ADPKD without subsequent counseling sessions.
Group II: Daily Caloric RestrictionExperimental Treatment1 Intervention
The daily caloric restriction group will participate in a 2-year, group-based, behavioral weight loss intervention based on a 30% reduction in caloric intake and increased physical activity.
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,212 Previous Clinical Trials
3,766,912 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,465 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,400 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 65 years old.My kidneys are larger than normal, as shown by a recent scan.I have diabetes.You have a problem with drinking too much alcohol or being dependent on it.I have untreated high cholesterol.I regularly take medication that can affect my weight or appetite.I had obesity surgery or a weight loss device, but it was removed over a year ago.My BMI is between 25 and 45.My heart's rhythm is irregular or I have a serious heart condition.You have a serious mental health condition like schizophrenia or severe depression that could make it hard for you to follow the study's dietary plans.I do not have heart or blood vessel diseases, nor do I experience chest pain, shortness of breath with little effort, or fainting.You have been diagnosed with ADPKD based on specific criteria called the modified Pei-Ravine criteria.My high blood pressure is not under control.I have not been hospitalized or had major surgery in the last 3 months.You have smoked within the last 12 months.I have been diagnosed with an eating disorder such as anorexia, bulimia, or binge eating.I won't travel for more than 2 weeks without internet for the next year.I have a serious lung condition like COPD, lung scarring, cystic fibrosis, or severe asthma.I have lost more than 5% of my weight in the last 3 months, not due to childbirth.My kidney function is at a safe level for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Daily Caloric Restriction
- Group 2: Standard Advice Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research study recruiting individuals aged 40 or above?
"This study is limited to patients between the ages of 18-65. Alternatively, there are 58 trials accessible for minors and 218 studies available to seniors."
Answered by AI
How many individuals are eligible to join this research endeavor?
"Affirmative. Evidenced by the information hosted on clinicaltrials.gov, this medical endeavour is presently accepting patients for enrolment. Originally posted on November 3 2021 and most recently updated on September 23 2022, 126 participants are sought from a single site."
Answered by AI
What is the ideal demographic for this experiment?
"This medical trial is currently enlisting 126 individuals who have a diagnosis of autosomal dominant polycystic kidney disease. To be accepted, applicants must fulfill the following criteria: between 18-65 years old; BMI ranging from 25 to 45 kg/m^2; total kidney volume greater than 600 mL as documented in a recent ultrasound or MRI scan within 12 months; modified Pei-Ravine criteria for ADPKD determination; glomerular filtration rate higher that 30mL/min/1.73 m^2 and access to internet with video chat features accessible. Moreover, participants cannot travel without web connection for more than"
Answered by AI
Is recruitment for this research endeavor still ongoing?
"The clinical trial is actively recruiting participants, as noted on the website of clinicaltrials.gov which first posted this medical study on November 3rd 2021 and updated it most recently on September 23rd 2022."
Answered by AI
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