Daily Caloric Restriction in ADPKD

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Brief Title

Daily Caloric Restriction in ADPKD

Official Title

Daily Caloric Restriction in Overweight and Obese Adults With ADPKD

Brief Summary

      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.
    

Detailed Description

      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 suggests that a metabolic defect exists in ADPKD, which
      likely contributes to cystic epithelial proliferation and subsequent cyst growth.
      Additionally, the investigators recently reported that overweight and obesity are strong
      independent predictors of more rapid kidney growth. Collectively, these data suggest that
      interventions to reduce abdominal adiposity may slow ADPKD progression.

      Initial results from the investigators' R03-funded pilot and feasibility study support that a
      12-month daily caloric restriction (DCR)-based behavioral weight loss intervention in adults
      with ADPKD and overweight or obesity: 1) is feasible and acceptable; 2) slowed kidney growth
      (annual %∆ in height-adjusted TKV [htTKV]), which was highly correlated with weight loss; 3)
      reduced abdominal adiposity; and 4) altered pathways implicated in ADPKD progression and
      metabolism. These initial results suggest that a DCR-based behavioral weight loss
      intervention offers a promising strategy to slow ADPKD progression. However, the pilot and
      feasibility study was limited by a small sample size, relatively short duration, and lack of
      a control group. Thus, to translate these promising results of the pilot study towards
      clinical practice, the investigators are conducting a randomized, controlled clinical trial
      in a larger number of adults with ADPKD and overweight or obesity to directly compare the
      efficacy of a DCR-based behavioral weight loss intervention compared to control for slowing
      kidney growth (primary outcome) over a longer duration. Changes in abdominal adiposity will
      serve as a secondary outcome and effects of weight loss on circulating and adipose markers of
      biological pathways will provide mechanistic insight.
    


Study Type

Interventional


Primary Outcome

Change in height-Adjusted Total kidney volume

Secondary Outcome

 Change in abdominal adiposity

Condition

Autosomal Dominant Polycystic Kidney

Intervention

Daily caloric restriction

Study Arms / Comparison Groups

 Daily Caloric Restriction
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

126

Start Date

September 1, 2021

Completion Date

July 2026

Primary Completion Date

July 2026

Eligibility Criteria

        Inclusion Criteria:

          -  18-65 years of age

          -  ADPKD diagnosis based on the modified Pei-Ravine criteria

          -  Body-mass index of 27-45 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 another interventional study or weight loss program

          -  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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Kristen Nowak, PhD, MPH, 303-724-4842, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04907799

Organization ID

21-2999

Secondary IDs

R01DK129259

Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver

Collaborators

 Mayo Clinic

Study Sponsor

Kristen Nowak, PhD, MPH, Principal Investigator, University of Colorado - Anschutz Medical Campus


Verification Date

September 2021