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Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342742
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE June 4, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Feasibility to enroll and retain participants [ Time Frame: Through study completion, an expected duration of 18 months ]
    Numbers of individuals pre-screened
  • Feasibility to enroll participants [ Time Frame: Through study completion, an expected duration of 18 months ]
    Numbers of individuals screened
  • Feasibility to retain participants [ Time Frame: Through study completion, an expected duration of 18 months ]
    Numbers of individuals enrolled
  • Feasibility to retain participants [ Time Frame: Through study completion, an expected duration of 18 months ]
    Numbers of individuals retained
  • Change in Weight Loss [ Time Frame: Baseline, 12 weeks, and 1 year ]
    Measurement of body weight pre to post intervention in each group
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Feasibility to enroll and retain participants [ Time Frame: Through study completion, an expected duration of 6 months ]
    Numbers of individuals pre-screened
  • Feasibility to enroll participants [ Time Frame: Through study completion, an expected duration of 6 months ]
    Numbers of individuals screened
  • Feasibility to retain participants [ Time Frame: Through study completion, an expected duration of 6 months ]
    Numbers of individuals enrolled
  • Feasibility to retain participants [ Time Frame: Through study completion, an expected duration of 6 months ]
    Numbers of individuals retained
  • Change in Weight Loss [ Time Frame: Baseline and 12 weeks ]
    Measurement of body weight pre to post intervention in each group
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 16, 2018)
  • Safety and tolerability, measured as adverse events [ Time Frame: 12 weeks and 1 year ]
    Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
  • Safety and tolerability, measured as treatment-related adverse events [ Time Frame: 12 weeks and 1 year ]
    Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
  • Changes in quality of life [ Time Frame: Baseline, 12 weeks and 1 year ]
    Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score.
  • Changes in mood [ Time Frame: Baseline, 12 weeks and 1 year ]
    Mood state will be assessed with the Profile of Mood States 2 (POMS-2)
  • Change in energy intake [ Time Frame: Baseline, 12 weeks and 1 year ]
    Self-reported energy intake
  • Change in macronutrient intake [ Time Frame: Baseline, 12 weeks and 1 year ]
    Self-reported macronutrient intake
  • Change in serum insulin-like growth factor-1 levels [ Time Frame: Baseline, 12 weeks and 1 year ]
    Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
  • Change in insulin-like growth factor binding protein-1 levels [ Time Frame: Baseline, 12 weeks and 1 year ]
    Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
  • Change in PBMC AMPK expression [ Time Frame: Baseline, 12 weeks and 1 year ]
    Peripheral blood mononuclear cell protein expression of AMP-activated kinase (AMPK) in each group
  • Change in PBMC S6K expression [ Time Frame: Baseline, 12 weeks and 1 year ]
    Peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group
  • Change in β-hydroxybutyrate levels [ Time Frame: Baseline, 12 weeks and 1 year ]
    Serum β-hydroxybutyrate levels in each group
  • Change in total kidney volume by magnetic resonance imaging (MRI) [ Time Frame: Baseline, 12 weeks and 1 year ]
    Change in total kidney volume by MRI in each group
Original Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Safety and tolerability, measured as adverse events [ Time Frame: 12 weeks ]
    Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
  • Safety and tolerability, measured as treatment-related adverse events [ Time Frame: 12 weeks ]
    Number of participants with treatment-related adverse events in each group as evaluated by the Safety Officer
  • Changes in quality of life [ Time Frame: Baseline and 12 weeks ]
    Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score.
  • Changes in mood [ Time Frame: Baseline and 12 weeks ]
    Mood state will be assessed with the Profile of Mood States 2 (POMS-2)
  • Change in energy intake [ Time Frame: Baseline and 12 weeks ]
    Self-reported energy intake
  • Change in macronutrient intake [ Time Frame: Baseline and 12 weeks ]
    Self-reported macronutrient intake
  • Change in serum insulin-like growth factor-1 levels [ Time Frame: Baseline and 12 weeks ]
    Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
  • Change in insulin-like growth factor binding protein-1 levels [ Time Frame: Baseline and 12 weeks ]
    Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
  • Change in PBMC AMPK expression [ Time Frame: Baseline and 12 weeks ]
    Peripheral blood mononuclear cell protein expression of AMP-activated kinase (AMPK) in each group
  • Change in PBMC S6K expression [ Time Frame: Baseline and 12 weeks ]
    Peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group
  • Change in β-hydroxybutyrate levels [ Time Frame: Baseline and 12 weeks ]
    Serum β-hydroxybutyrate levels in each group
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
Official Title  ICMJE Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
Brief Summary The proposed research will determine the feasibility of delivering two behavioral weight loss interventions for 1 year in adults with autosomal dominant polycystic kidney disease (ADPKD) who are overweight or obese. The study will also compare these two interventions in terms of safety, acceptability, and tolerability. Last, this pilot trial will provide initial insight into a) biological changes and b) changes in kidney growth with each of the two weight loss interventions.
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. Surprisingly, the role of obesity in ADPKD progression is currently unknown. The investigators have novel preliminary data that overweight and obesity are independently associated with substantially faster kidney growth in ADPKD patients. Furthermore, in rodent models of ADPKD, mild-to-moderate food restriction profoundly slows cyst growth and maintains renal function via mechanisms including AMPK-activated kinase pathway activation and suppression of mammalian target of rapamycin/S6 kinase signaling and insulin-like growth factor-1 levels. Collectively, these data suggest that dietary restriction regimens may slow ADPKD progression. Accordingly, the primary aim is to determine the feasibility of delivering a 1 year behavioral weight loss intervention program in 30 overweight/obese adults with ADPKD, based on either daily caloric restriction (DCR) or intermittent fasting (IMF), with a similar (~34%) targeted weekly energy deficit. A key secondary goal is to evaluate safety, acceptability, and tolerability of IMF in ADPKD versus DCR. Last, the third exploratory aim is to a) obtain mechanistic insight into biological pathways that may be altered and b) provide initial insight into any changes in total kidney volume by magnetic resonance imaging with IMF and/or DCR.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Polycystic Kidney, Autosomal Dominant
Intervention  ICMJE Behavioral: Weight Loss
Weight loss behavioral intervention via one of two strategies.
Study Arms  ICMJE
  • Experimental: Daily Caloric Restriction
    The daily caloric restriction group will be instructed to reduce energy intake by a 34% daily energy deficit from baseline individual weight maintenance energy requirements.
    Intervention: Behavioral: Weight Loss
  • Experimental: Intermittent Fasting
    Participants in the intermittent fasting group will be instructed to reduce energy intake to ~20% of estimated energy requirement (delivered as a single meal) three non-consecutive days per week, resulting in a weekly energy deficit of ~34% (similar to the daily caloric restriction group).
    Intervention: Behavioral: Weight Loss
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 24, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
40
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 18-65 years
  2. ADPKD diagnosis based on the modified Pei-Ravine criteria
  3. BMI 25-45 kg/m^2
  4. Normal to mildly declined renal function with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 by the CKD-EPI equation
  5. Access to the internet with video chat capabilities
  6. No plans for extended travel (>2 weeks) during the 3 month intesive period
  7. Not currently participating in another interventional study or weight loss program
  8. Ability to provide informed consent

Exclusion Criteria:

  1. Diabetes mellitus (diagnosis or fasting glucose >126 mg/dL or Hemoglobin A1C >6.5%)
  2. Current nicotine use or history of use in the past 12 months
  3. Alcohol or substance abuse (self-report or undergoing treatment)
  4. History of hospitalization or major surgery within the last 3 months
  5. Untreated dyslipidemia (low density lipoprotein cholesterol > 190 mg/dL or triglycerides >400 mg/dL)
  6. Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg)
  7. Pregnancy, lactation, or unwillingness to use adequate birth control
  8. Cardiovascular disease, peripheral vascular disease, cerebrovascular disease, significant pulmonary or gastrointestinal disease (described below), cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis)
  9. Abnormal resting electrocardiogram (ECG): serious arrhythmias, including multifocal 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
  10. Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active gallbladder disease
  11. Significant pulmonary disorders including: chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, or uncontrolled asthma
  12. Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism (e.g. appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants; Study M.D. will be consulted as needed; antibiotics started during the intervention period are not an exclusion); regular use of obesity pharmacotherapeutic agents within the last 6 month
  13. History of clinically diagnosed eating disorder including anorexia nervosa, bulimia, binge eating disorder
  14. Weight loss >5% in past 3 months for any reason except post-partum weight loss; weight gain >5% in past 3 months requires assessment by PI to determine reason for weight gain and if it is appropriate for the subject to participate in the study.
  15. Untreated hyper- or hyperthyroidism (TSH outside of normal range for laboratory or history of uncontrolled thyroid disorder). History of thyroid disorder or current thyroid disease treated with stable medication regimen for at least 6 months in acceptable.
  16. Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode.
  17. History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary interventions.
  18. Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03342742
Other Study ID Numbers  ICMJE 17-1327
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristen Nowak, Ph.D., MPH University of Colorado - Anschutz Medical Campus
PRS Account University of Colorado, Denver
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP