Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD
Running, not enrolling · Not applicable
Conditions studied: Autosomal Dominant Polycystic Kidney
In brief
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.
Key facts
- Study ID
- NCT06496542
- Run by
- University of Colorado, Denver
- People needed
- 14
- Starts
- 2023-01-13
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
- 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 it is running
- University of Colorado- Anschutz Medical Campus — Aurora, Colorado, United States
Full record on ClinicalTrials.gov
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