Status:
ACTIVE_NOT_RECRUITING
Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Nutrition Obesity Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Autosomal Dominant Polycystic Kidney
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Autosomal dominant polycystic kidney disease (ADPKD) is the most commonly inherited progressive kidney disease. Overweight and obese phenotypes have been associated with disease progression in early-s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06496542
Start Date
January 13 2023
End Date
July 1 2026
Last Update
August 21 2025
Active Locations (1)
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1
University of Colorado- Anschutz Medical Campus
Aurora, Colorado, United States, 80045