Overweight and Obesity Clinical Trial
Official title:
Daily Caloric Restriction in Overweight and Obese Adults With ADPKD
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.
Status | Recruiting |
Enrollment | 126 |
Est. completion date | July 1, 2026 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado - Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Mayo Clinic, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Safety (adverse events) | Number of participants with treatment-related adverse events in each group as evaluated by the DSMB | 24-months | |
Other | Change in dietary Energy Intake | Multiple pass 24-hr dietary recalls will be analyzed to evaluate self-reported energy intake | Baseline, 1-, 6-, 12-, and 24-months | |
Other | Adherence | Self-reported dietary adherence using a 1-10 likert scale (10 is highest adherence) | 24 months | |
Other | Tolerability (dropout due to adverse events) | Subject dropout due to treatment-emergent adverse events | 24 months | |
Other | Change in free-living physical activity | Estimated energy expenditure (METs) over a 7-day period will be quantified using the activPAL3 micro. | Baseline, 6-, 12- and 24-months | |
Other | Change in percent body fat | Percent body fat will be assessed via DEXA scan in a sub-set of participants. | Baseline, 24-months | |
Other | Change in plasma choline | Plasma choline will be analyzed by high-performance liquid chromatography-tandem mass spectrometry in a sub-set of participants. | Baseline, 24-months | |
Other | Change in plasma trimethylamine | Plasma trimethylamine will be analyzed by high-performance liquid chromatography-tandem mass spectrometry in a sub-set of participants. | Baseline, 24-months | |
Other | Change in plasma trimethylamine-N-oxide | Plasma trimethylamine-N-oxide will be analyzed by high-performance liquid chromatography-tandem mass spectrometry in a sub-set of participants. | Baseline, 24-months | |
Primary | Change in height-Adjusted Total kidney volume | To assess kidney growth, we will measure height-adjusted total kidney volume by magnetic resonance imaging at baseline and 24 months to determine annual percent change. | Baseline, 24-months | |
Secondary | Change in abdominal adiposity | Abdominal adiposity (subcutaneous, visceral, and total) will be assessed by magnetic resonance imaging. | Baseline, 24-months | |
Secondary | Change in the ratio of insulin-like growth factor-1 (IGF-1)/ to GF binding protein-1 | Venous blood samples will be analyzed for this mechanistic biomarker | Baseline, 12-months, 24-months | |
Secondary | Change in adiponectin (circulating) | Venous blood samples will be analyzed for this mechanistic biomarker | Baseline, 12-months, 24-months | |
Secondary | Change in leptin (circulating) | Venous blood samples will be analyzed for this mechanistic biomarker | Baseline, 12-months, 24-months | |
Secondary | Change in intereukin-6 (circulating) | Venous blood samples will be analyzed for this mechanistic biomarker | Baseline, 12-months, 24-months | |
Secondary | Change in tumor necrosis factor-alpha (circulating) | Venous blood samples will be analyzed for this mechanistic biomarker | Baseline, 12-months, 24-months | |
Secondary | Change in C-reactive protein (circulating) | Venous blood samples will be analyzed for this mechanistic biomarker | Baseline, 12-months, 24-months | |
Secondary | Change in peripheral blood mononuclear cell protein expression of pAMPK/AMPK | PBMCs will be isolated from whole blood to assess protein expression | Baseline, 12-months, 24-months | |
Secondary | Change in peripheral blood mononuclear cell protein expression of pS6K/S6K | PBMCs will be isolated from whole blood to assess protein expression | Baseline, 12-months, 24-months | |
Secondary | Change in adiponectin (adipose tissue) | A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker. | Baseline, 24-months | |
Secondary | Change in leptin (adipose tissue) | A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker. | Baseline, 24-months | |
Secondary | Change in interleukin-6 (adipose tissue) | A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker. | Baseline, 24-months | |
Secondary | Change in tumor necrosis factor-alpha (adipose tissue) | A subcutaneous adipose tissue biopsy will be performed for assessment of this mechanistic biomarker. | Baseline, 24-months | |
Secondary | Change in renal oxygen consumption | Renal oxygen consumption will be assessed by a PET/CT scan using 11-C acetate in a sub-set of participants | Baseline, 24-months | |
Secondary | Change in gut microbiota | 16S rRNA gene sequencing will be used for taxonomic characterization of the gut microbiota in a subset of participants. | Baseline, 24-months | |
Secondary | Change in plasma metabolome | Untargeted plasma metabolomics will be performed using high-performance liquid chromatography-tandem mass spectrometry in a subset of participants. | Baseline, 24-months |
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