Weight loss intervention for kidney health in ADPKD patients
Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in Autosomal Dominant Polycystic Kidney Disease (EXPLORE Study)
This study is testing if losing weight through daily calorie cutting can improve kidney health and function in overweight or obese adults with autosomal dominant polycystic kidney disease (ADPKD).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06496542 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of a two-year daily caloric restriction intervention on kidney oxidative metabolism and insulin sensitivity in overweight or obese adults with autosomal dominant polycystic kidney disease (ADPKD). Participants will undergo assessments using 11C-acetate PET scans and hyperinsulinemic-euglycemic clamps to evaluate changes in kidney function and metabolism. The study aims to determine how weight loss impacts kidney health and disease progression in ADPKD patients. It leverages data from an ongoing trial to compare outcomes between a caloric restriction group and a control group over the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of ADPKD, a BMI between 25-45 kg/m², and specific kidney function criteria.
Not a fit: Patients with diabetes, uncontrolled hypertension, or those currently participating in other weight loss programs may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could slow the progression of kidney disease in patients with ADPKD by improving kidney metabolism and insulin sensitivity.
How similar studies have performed: While this approach is novel in the context of ADPKD, similar studies in other conditions have shown promising results with caloric restriction and metabolic health.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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.
Where this trial is running
Aurora, Colorado
- University of Colorado- Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Cortney Steele, PhD
- Email: cortney.steele@cuanschutz.edu
- Phone: 303-724-0673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.