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NCT04907799Active, not recruiting

Daily Caloric Restriction in ADPKD

Daily Caloric Restriction in Overweight and Obese Adults With ADPKD

Source: ClinicalTrials.gov · Last updated 12 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
125 (actual)
First submitted
25 May 2021
Start date
3 Nov 2021
Primary completion date
30 Jun 2027
Lead sponsor
University of Colorado, Denver
NCT number
NCT04907799

What you commit to

  • Study type: Interventional
  • Participants enrolled: 125
  • From 3 Nov 2021 to the primary completion date, 30 Jun 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism unless weight stable
  • Inability to cooperate with or clinical contraindication for magnetic resonance imaging, including: severe claustrophobia, implants, devices, or non-removable body piercings
  • Previous obesity treatment with surgery or weight loss device, except: (1) liposuction and/or abdominoplasty if performed \> 1 year before screening, (2) lap banding if the band has been removed \> 1 year before screening, (3) intragastric balloon if the balloon has been removed \> 1 year before screening (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening or 5) AspireAssist or other endoscopically placed weight loss device if the device has been removed \> 1 year before screening.

Other illness

  • Diabetes mellitus
  • Current smokers or history of smoking in the past 12 months
  • History of hospitalization or major surgery within the last 3 months
  • Uncontrolled hypertension
  • Cardiovascular disease, peripheral vascular disease, or symptoms suggestive of cardiovascular disease: chest pain, shortness of breath at rest or with mild exertion, syncope
  • Significant pulmonary disease including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
  • History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
  • 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)

Lab values

  • 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

Other

  • Alcohol dependence or abuse
  • Untreated dyslipidemia
  • Pregnancy, lactation, or unwillingness to use adequate birth control
  • Weight loss of \>5% in the past 3 months for any reason except post-partum weight loss; weight gain \>5% requires assessment by PI

Who the study is looking for

  • 18-65 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Anschutz Medical Campus
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.