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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

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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I have untreated high cholesterol.

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My heart's rhythm is irregular or I have a serious heart condition.

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I do not have heart or blood vessel diseases, nor do I experience chest pain, shortness of breath with little effort, or fainting.

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My high blood pressure is not under control.

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I have been diagnosed with an eating disorder such as anorexia, bulimia, or binge eating.

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I have a serious lung condition like COPD, lung scarring, cystic fibrosis, or severe asthma.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-, 6-, 12-, and 24-months for reporting.

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 more

Other study objectives

Adherence

Change in dietary Energy Intake

Change in free-living physical activity

+6 more

Awards & 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.

0 / 12Eligibility criteria met