- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342742
Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
February 8, 2022 updated by: University of Colorado, Denver
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- Kristen Nowak
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18-65 years
- ADPKD diagnosis based on the modified Pei-Ravine criteria
- BMI 25-45 kg/m^2
- Normal to mildly declined renal function with an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 by the CKD-EPI equation
- Access to the internet with video chat capabilities
- No plans for extended travel (>2 weeks) during the 3 month intesive period
- Not currently participating in another interventional study or weight loss program
- Ability to provide informed consent
Exclusion Criteria:
- Diabetes mellitus (diagnosis or fasting glucose >126 mg/dL or Hemoglobin A1C >6.5%)
- Current nicotine use or history of use in the past 12 months
- Alcohol or substance abuse (self-report or undergoing treatment)
- History of hospitalization or major surgery within the last 3 months
- Untreated dyslipidemia (low density lipoprotein cholesterol > 190 mg/dL or triglycerides >400 mg/dL)
- Uncontrolled hypertension (systolic blood pressure > 160 or diastolic blood pressure >100 mm Hg)
- Pregnancy, lactation, or unwillingness to use adequate birth control
- 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)
- 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
- Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, ulcerative colitis, chronic diarrhea, or active gallbladder disease
- Significant pulmonary disorders 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 (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
- History of clinically diagnosed eating disorder including anorexia nervosa, bulimia, binge eating disorder
- 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.
- 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.
- Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode.
- 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.
- Inability to cooperate with/clinical contraindication for MRI including severe claustrophobia, implants, devices, or non-removable body piercings
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Weight loss behavioral intervention via one of two strategies.
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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).
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Weight loss behavioral intervention via one of two strategies.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility to Enroll and Retain Participants
Time Frame: Through study completion, an expected duration of 18 months
|
Numbers of individuals pre-screened
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Through study completion, an expected duration of 18 months
|
Feasibility to Enroll Participants
Time Frame: Through study completion, an expected duration of 18 months
|
Numbers of individuals screened
|
Through study completion, an expected duration of 18 months
|
Feasibility to Retain Participants
Time Frame: Through study completion, an expected duration of 18 months
|
Numbers of individuals enrolled
|
Through study completion, an expected duration of 18 months
|
Feasibility to Retain Participants
Time Frame: Through study completion, an expected duration of 18 months
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Numbers of individuals retained
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Through study completion, an expected duration of 18 months
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Percent Change From Baseline Body Weight (Weight Loss)
Time Frame: Baseline, 12 weeks, and 1 year
|
Measurement of body weight pre to post intervention in each group
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Baseline, 12 weeks, and 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Tolerability, Measured as Adverse Events
Time Frame: 1 year
|
Number of participants with treatment-related adverse events in each group as evaluated by monthly phone questionnaire
|
1 year
|
Quality of Life Scores at Baseline
Time Frame: Baseline
|
Quality of life (QOL) will be assessed with the RAND 36 Item Health Survey (RAND-36) physical and mental health component summary score.
The Rand-36 measures quality of life.
Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.
|
Baseline
|
Quality of Life Scores at 12 Weeks
Time Frame: 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.
The Rand-36 measures quality of life.
Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.
|
12 Weeks
|
Quality of Life Scores at 1 Year
Time Frame: 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.
The Rand-36 measures quality of life.
Possible scores for each subscale range from 0 to 100, with higher scores indicating a better quality of life and better outcome.
|
1 Year
|
Mood at Baseline
Time Frame: Baseline
|
Mood state will be assessed with the Profile of Mood States 2 (POMS-2).
The POMS-2 measures mood.
Possible scores for the Vigor scale range from 0 to 32, with higher scores for indicating a better outcome.
Possible scores for the fatigue scale range from 0 to 28 with higher scores indicating a worse outcome.
|
Baseline
|
Mood at 12 Weeks
Time Frame: 12 Weeks
|
Mood state will be assessed with the Profile of Mood States 2 (POMS-2).
The POMS-2 measures mood.
Possible scores range from 0 to 20 for both the Vigor and Fatigue subscales, with higher scores indicating a worse outcome.
|
12 Weeks
|
Mood at 1 Year
Time Frame: 1 Year
|
Mood state will be assessed with the Profile of Mood States 2 (POMS-2).
The POMS-2 measures mood.
Possible scores range from 0 to 20 for both the Vigor and Fatigue subscales, with higher scores indicating a worse outcome.
|
1 Year
|
Change in Energy Intake
Time Frame: Baseline, 12 weeks and 1 year
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Self-reported energy intake
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Baseline, 12 weeks and 1 year
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Change in Macronutrient Intake
Time Frame: Baseline, 12 weeks and 1 year
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Self-reported macronutrient intake
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Baseline, 12 weeks and 1 year
|
Serum Insulin-like Growth Factor-1 Levels at Baseline
Time Frame: Baseline
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Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
|
Baseline
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Serum Insulin-like Growth Factor-1 Levels at 12 Weeks
Time Frame: 12 Weeks
|
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
|
12 Weeks
|
Serum Insulin-like Growth Factor-1 Levels at 1 Year
Time Frame: 1 Year
|
Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
|
1 Year
|
Insulin-like Growth Factor Binding Protein-1 Levels at Baseline
Time Frame: Baseline
|
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
|
Baseline
|
Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks
Time Frame: 12 Weeks
|
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
|
12 Weeks
|
Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year
Time Frame: 1 Year
|
Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group
|
1 Year
|
Change in PBMC Ratio of pS6K/s6K
Time Frame: Baseline and 1 year
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Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group.
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Baseline and 1 year
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Change in PBMC pAMPK/AMPK Expression
Time Frame: Baseline and 1 year
|
Ratio of peripheral blood mononuclear cell protein expression of phosphorylated AMP-activated kinase (AMPK) to AMPK in each group
|
Baseline and 1 year
|
Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI)
Time Frame: Baseline and 1 year
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Percent change from baseline in height adjusted total kidney volume by MRI in each group
|
Baseline and 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kristen Nowak, Ph.D., MPH, University of Colorado - Anschutz Medical Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 4, 2018
Primary Completion (Actual)
October 13, 2020
Study Completion (Actual)
October 13, 2020
Study Registration Dates
First Submitted
October 27, 2017
First Submitted That Met QC Criteria
November 13, 2017
First Posted (Actual)
November 17, 2017
Study Record Updates
Last Update Posted (Actual)
March 3, 2022
Last Update Submitted That Met QC Criteria
February 8, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urologic Diseases
- Congenital Abnormalities
- Body Weight
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Kidney Diseases
- Overweight
- Polycystic Kidney Diseases
- Polycystic Kidney, Autosomal Dominant
- Arthrogryposis
Other Study ID Numbers
- 17-1327
- R03DK118215 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Data obtained through this study may be provided to qualified researchers with academic interest in ADPKD.
Data shared will be coded, with no PHI included.
Approval of the request and execution of all applicable agreements (i.e.
data use agreement) are prerequisites to the sharing of data with the requesting party.
IPD Sharing Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months.
Extensions will be considered on a case-by-case basis.
IPD Sharing Access Criteria
Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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