Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD (NCT06496542) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD
United States14 participantsStarted 2023-01-13
Plain-language 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 who are overweight or obese.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 deg…