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Behavioral Intervention

Caloric Restriction for Polycystic Kidney Disease (EXPLORE Trial)

N/A

Recruiting

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

Estimated glomerular filtration rate ≥ 30 mL/min/1.73m^2

Must not have

Abnormal resting electrocardiogram (ECG): serious arrhythmias, including multifocal premature ventricular contractions (PVC's), frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval > 480 msec or other significant conduction defects

Weight loss of >5% in the past 3 months for any reason except post-partum weight loss; weight gain >5% requires assessment by PI

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 24-months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how losing weight over 2 years can affect kidney function and insulin sensitivity in people with a specific kidney disease.

Who is the study for?

This trial is for overweight or obese adults aged 18-65 with autosomal dominant polycystic kidney disease (ADPKD) and a body-mass index of 25-45 kg/m^2. Participants must have internet access, not be in other weight loss programs, and have a certain level of kidney function. Exclusions include serious heart conditions, recent significant weight changes, diabetes, substance abuse issues, major psychiatric disorders, inability to undergo MRI scans, smoking history within the past year.

What is being tested?

The study tests how daily caloric restriction over two years affects kidney oxidative metabolism and insulin sensitivity in ADPKD patients compared to standard advice control. It's designed as a pilot study where participants are given specific dietary interventions to follow.

What are the potential side effects?

While the trial description does not specify side effects related to daily caloric restriction or standard advice control directly, potential general side effects may include fatigue due to lower energy intake from dieting.

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 kidney function is adequate.

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My kidney size is larger than normal, as shown by recent scans.

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My BMI is between 25 and 45.

Exclusion Criteria

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

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

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I have lost more than 5% of my weight in the last 3 months, not due to childbirth.

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I have diabetes.

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

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I am a current smoker or have smoked in the last year.

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I have not received treatment for high cholesterol.

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My blood pressure is not well-controlled.

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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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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, 24-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 24-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 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 insulin sensitivity

Change in renal oxygen consumption

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: Other: 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 / 13Eligibility criteria met