Daily Caloric Restriction in ADPKD

NCT04907799 | Active Not Recruiting DMC

• 2 other identifiers: 21-2999R01DK129259
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will determine whether a daily-caloric restriction-based weight loss intervention can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat by magnetic resonance imaging. Blood and fat samples will provide insight into biological changes that may contribute to any observed benefits of the intervention.

Conditions

Autosomal Dominant Polycystic Kidney; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• Change in height-Adjusted Total kidney volume

  To assess kidney growth, we will measure height-adjusted total kidney volume by magnetic resonance imaging at baseline and 24 months to determine annual percent change.

  Baseline, 24-months

Secondary Outcomes (16)

• Change in abdominal adiposity

  Baseline, 24-months

• Change in the ratio of insulin-like growth factor-1 (IGF-1)/ to GF binding protein-1

  Baseline, 12-months, 24-months

• Change in adiponectin (circulating)

  Baseline, 12-months, 24-months

• Change in leptin (circulating)

  Baseline, 12-months, 24-months

• Change in interleukin-6 (circulating)

  Baseline, 12-months, 24-months

Other Outcomes (9)

• Safety (adverse events)

  24-months

• Change in dietary Energy Intake

  Baseline, 1-, 6-, 12-, and 24-months

• Adherence

  24 months

Study Arms (2)

Daily Caloric Restriction

EXPERIMENTAL

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.

Behavioral: Daily caloric restriction

Standard Advice Control

OTHER

The standard advice control group will receive an initial consultation with a registered dietician regarding current clinical recommendations for ADPKD without subsequent counseling sessions.

Other: Standard advice control

Interventions

Daily caloric restriction BEHAVIORAL

Weight loss based on daily caloric restriction and increased physical activity

Daily Caloric Restriction

Standard advice control OTHER

Initial nutrition consultation without subsequent counseling

Standard Advice Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• ADPKD diagnosis based on the modified Pei-Ravine criteria
• Body-mass index of 25-45 kg/m\^2
• Estimated glomerular filtration rate ≥ 30 mL/min/1.73m\^2
• Total kidney volume (htTKV) \> 600 mL, calculated/estimated from a previous kidney ultrasound or magnetic resonance imaging
• Access to the internet with video chat capabilities
• No plans for extended travel (\>2 weeks) without internet access during the 12-month intensive period
• Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study
• Ability to provide informed consent

You may not qualify if:

• Diabetes mellitus
• Current smokers or history of smoking in the past 12 months
• Alcohol dependence or abuse
• History of hospitalization or major surgery within the last 3 months
• Untreated dyslipidemia
• Uncontrolled hypertension
• Pregnancy, lactation, or unwillingness to use adequate birth control
• Cardiovascular disease, peripheral vascular disease, or symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, syncope
• 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
• Significant pulmonary disease including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
• Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism unless weight stable
• History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
• Weight loss of \>5% in the past 3 months for any reason except post-partum weight loss; weight gain \>5% requires assessment by PI
• Major psychiatric disorder (e.g., psychosis, schizophrenia, mania, bipolar disorder) or current severe depression, based on DSM-IV-TR criteria for Major Depressive Episode, which in the opinion of the Study MD would interfere with ability to adhere to dietary interventions)
• Inability to cooperate with or clinical contraindication for magnetic resonance imaging, including: severe claustrophobia, implants, devices, or non-removable body piercings

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Mayo Clinic: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• Cortinovis M, Perico N, Remuzzi G. The Need for Novel Therapeutic Directions in Autosomal Dominant Polycystic Kidney Disease Patient Care. Clin J Am Soc Nephrol. 2025 Dec 5. doi: 10.2215/CJN.0000000975. Online ahead of print.

  PMID: 41348481 DERIVED

• Nowak KL, Copeland TP, Ku E, Sarnak MJ, Gitomer B, Abebe KZ, Chapman A, Perrone R, Rahbari-Oskoui FF, Steinman T, Yu ASL, Chonchol M. Overweight Status, Obesity, and Progression to ESKD in Patients with Autosomal Dominant Polycystic Kidney Disease. Clin J Am Soc Nephrol. 2025 Apr 1;20(4):520-528. doi: 10.2215/CJN.0000000640. Epub 2025 Feb 19.

  PMID: 39970002 DERIVED

• Chebib FT, Nowak KL, Chonchol MB, Bing K, Ghanem A, Rahbari-Oskoui FF, Dahl NK, Mrug M. Polycystic Kidney Disease Diet: What is Known and What is Safe. Clin J Am Soc Nephrol. 2024 May 1;19(5):664-682. doi: 10.2215/CJN.0000000000000326. Epub 2023 Sep 20.

  PMID: 37729939 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Overweight; Obesity

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristen Nowak, PhD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 1, 2021
• Study Start: November 3, 2021
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)