Renal Oxygen Consumption, Insulin Sensitivity, and Daily Caloric Restriction in ADPKD

NCT06496542 | Active Not Recruiting DMC

• 2 other identifiers: 22-0979P30DK048520
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autosomal Dominant Polycystic Kidney

Keywords

Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Change in renal oxygen consumption

  Renal oxygen consumption will be assessed by a PET/CT scan using 11-C acetate

  Baseline, 24-months

• Change in insulin sensitivity

  Insulin sensitivity will be assessed by a hyperinsulinemic-euglycemic clamp

  Baseline, 24-months

Study Arms (2)

Daily Caloric Restriction

EXPERIMENTAL

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.

Behavioral: Daily caloric restriction

Other: Standard Advice Control

OTHER

The standard advice control group will receive an initial consultation with a registered dietician regarding current clinical recommendations for ADPKD without subsequent counseling sessions.

Other: Standard advice control

Interventions

Daily caloric restriction BEHAVIORAL

Weight loss based on daily caloric restriction and increased physical activity

Daily Caloric Restriction

Standard advice control OTHER

Initial nutrition consultation without subsequent counseling

Other: Standard Advice Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of Colorado, Denver: lead
• Nutrition Obesity Research Center: collaborator

Study Sites (1)

University of Colorado- Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.

  PMID: 39356039 DERIVED

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant; Kidney Diseases

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: January 13, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)