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Dietary for Polycystic Kidney Disease

N/A

Waitlist Available

Led By Kristen Nowak

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will study the feasibility of a time restricted feeding intervention for people with a certain kidney disease who are overweight or obese. The study will look at safety, adherence, acceptability, and tolerability of the intervention.

Eligible Conditions

Polycystic Kidney Disease (PKD)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence

Feasibility to enroll participants

Feasibility to retain participants

Secondary outcome measures

Change in Abdominal adiposity

Change in Body Composition

Change in Body Weight

+10 more

Other outcome measures

Change in energy intake

Change in macronutrient intake

Change in resting energy expenditure

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time Restricted FeedingExperimental Treatment1 Intervention

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.

Group II: Healthy Eating Advice without Time Restricted FeedingActive Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary

2002

N/A

~590

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,554 Total Patients Enrolled

PKD FoundationOTHER

2 Previous Clinical Trials

3,624 Total Patients Enrolled

Kristen NowakPrincipal InvestigatorUniversity of Colorado, Denver

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria for enrollment in this research study?

"This study has a predetermined sample size of 30 and is accepting those with autosomal dominant polycystic kidney disease who are between 18-65 years old. Additionally, applicants must have internet access with video chat capability and a smartphone, be unenrolled in any other interventional program or weight loss regimen, and possess a BMI ranging from 25-45 kg/m^2."

Answered by AI

Is this research study presently open for enrollment?

"Per the information on clinicaltrials.gov, this trial is currently not recruiting candidates; it was first posted on February 9th 2021 and last updated May 16th 2022. While this particular study may be full at present time, there are 489 other medical trials actively looking for patients to join their research efforts."

Answered by AI

Is eligibility for this research limited to adults under 35 years of age?

"This clinical trial is exclusive to individuals aged 18 to 65. If a participant falls outside of this range, there are 45 studies for those under 18 and 448 studies for people over the age of 65."

Answered by AI

What do researchers anticipate to be the outcomes of this research endeavor?

"This medical trial is designed to evaluate the retention of participants over a 12 month period. Secondary objectives include assessing changes in fasting serum insulin-like growth factor binding protein-1 (IGFBP-1) levels, body composition via dual-energy X-ray absorptiometry (DEXA), and monthly body weight measurements taken with BodyTrace scales for remote data transmission."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease

2021. "Time Restricted Feeding in Autosomal Dominant Polycystic Kidney Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04534985.