ACTIVE_NOT_RECRUITING

Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD

Conditions

Autosomal Dominant Polycystic Kidney Kidney Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed research is a pilot study assessing kidney oxidative metabolism and insulin sensitivity after a 2-year weight loss intervention in those with autosomal dominant polycystic kidney disease who are overweight or obese.

Official Title

Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in Autosomal Dominant Polycystic Kidney Disease (EXPLORE Study)

Quick Facts

Study Start:2023-01-13

Study Completion:2026-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06496542

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 from a previous kidney ultrasound or magnetic resonance imaging performed within the last 12 months * 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	* 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 * 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 * 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.

Inclusion Criteria

Exclusion Criteria

* 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 from a previous kidney ultrasound or magnetic resonance imaging performed within the last 12 months
* 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

* 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
* 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
* 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.

Contacts and Locations

Study Locations (Sites)

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-13

Study Completion Date2026-07-01

Study Record Updates

Study Start Date2023-01-13

Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

Kidney Disease

Additional Relevant MeSH Terms

Autosomal Dominant Polycystic Kidney