Daily Caloric Restriction in Overweight and Obese Adults With ADPKD

Description

This clinical trial will determine whether a daily-caloric restriction-based weight loss intervention can slow kidney growth in adults with autosomal dominant polycystic kidney disease who are overweight or obese. The study will also evaluate changes in abdominal fat by magnetic resonance imaging. Blood and fat samples will provide insight into biological changes that may contribute to any observed benefits of the intervention.Autosomal dominant polycystic kidney disease (ADPKD) is characterized by development and continued growth of numerous fluid-filled renal cysts that ultimately result in renal failure. Similar to the general population, the prevalence of overweight and obesity have been rising in ADPKD patients, effecting about two-thirds of individuals. Adipocytes do not simply act as a fat reservoir, but are active endocrine organs that promote release of pro-inflammatory cytokines, and thus, may be a promising clinical target for ADPKD management. Mounting evidence also suggest

Trial Eligibility

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.

Study Info

Interventions

Locations Recruiting

Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.