← Back to Search
Caloric Restriction for Polycystic Kidney Disease
Aurora, CO
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
Must not have
Diabetes mellitus
Untreated dyslipidemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1-, 6-, 12-, and 24-months
Awards & highlights
No Placebo-Only Group
Summary
This trial will determine whether a weight loss intervention can slow kidney growth in adults with a certain kidney disease.
See full description
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.
show original
Select...
My kidneys are larger than normal, as shown by a recent scan.
show original
Select...
My BMI is between 25 and 45.
show original
Select...
I won't travel for more than 2 weeks without internet for the next year.
show original
Select...
My kidney function is at a safe level for the trial.
show original
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes.
show original
Select...
I have untreated high cholesterol.
show original
Select...
My heart's rhythm is irregular or I have a serious heart condition.
show original
Select...
I do not have heart or blood vessel diseases, nor do I experience chest pain, shortness of breath with little effort, or fainting.
show original
Select...
My high blood pressure is not under control.
show original
Select...
I have been diagnosed with an eating disorder such as anorexia, bulimia, or binge eating.
show original
Select...
I have a serious lung condition like COPD, lung scarring, cystic fibrosis, or severe asthma.
show original
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in height-Adjusted Total kidney volume
Secondary study objectives
Change in C-reactive protein (circulating)
Change in abdominal adiposity
Change in adiponectin (adipose tissue)
+13 moreOther study objectives
Adherence
Change in dietary Energy Intake
Change in free-living physical activity
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
Closest Location:University of Colorado - Anschutz Medical Campus· Aurora, CO
Who is running the clinical trial?
Mayo ClinicOTHER
3,422 Previous Clinical Trials
3,222,381 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,509 Previous Clinical Trials
4,366,072 Total Patients Enrolled
University of Colorado, DenverLead Sponsor
1,841 Previous Clinical Trials
3,028,145 Total Patients Enrolled
Kristen Nowak, PhD, MPHPrincipal InvestigatorUniversity of Colorado, Denver
1 Previous Clinical Trials
108 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.