Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in Autosomal Dominant Polycystic Kidney Disease (EXPLORE Study)
概览
- 阶段
- 不适用
- 干预措施
- Daily caloric restriction
- 疾病 / 适应症
- Autosomal Dominant Polycystic Kidney
- 发起方
- University of Colorado, Denver
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Change in renal oxygen consumption
- 状态
- 进行中（未招募）
- 最后更新
- 昨天
概览
简要总结
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.
详细描述
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-stage ADPKD. Daily caloric restriction (DCR, 34% restriction per day from baseline weight maintenance requirements) may aid in weight loss and ultimately slow ADPKD disease progression. Weight loss via DCR may cause alterations in kidney oxidative metabolism and insulin sensitivity that can affect ADPKD disease progression. This study aims to assess kidney oxidative metabolism via 11C-acetate PET scan protocol and insulin sensitivity via hyperinsulinemic-euglycemic clamp by leveraging an ongoing R01-funded trial (NCT04907799) in DCR (n=10) vs. control (n=10) groups at baseline (BSL) and 2 years. The study will utilize the clinical outcome measures performed in the parent trial to address the subsequent novel aims: Aim 1: Compare kidney oxidative metabolism and insulin sensitivity at BSL and 2 years in adults with ADPKD. Aim 2: Define the relations among changes in kidney oxidative metabolism, insulin sensitivity, total kidney volume, and weight over 2 years. Currently, it is unknown if weight loss via DCR modifies renal energy expenditure and substrate utilization.
研究者
入排标准
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Daily Caloric Restriction
The daily caloric restriction group will participate in a 2-year, group-based, behavioral weight loss intervention based on a 30% reduction in caloric intake and increased physical activity.
干预措施: Daily caloric restriction
Other: Standard Advice Control
The standard advice control group will receive an initial consultation with a registered dietician regarding current clinical recommendations for ADPKD without subsequent counseling sessions.
干预措施: Standard advice control
结局指标
主要结局
Change in renal oxygen consumption
时间窗: Baseline, 24-months
Renal oxygen consumption will be assessed by a PET/CT scan using 11-C acetate
Change in insulin sensitivity
时间窗: Baseline, 24-months
Insulin sensitivity will be assessed by a hyperinsulinemic-euglycemic clamp