Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease
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ClinicalTrials.gov Identifier: NCT03342742 |
Recruitment Status :
Completed
First Posted : November 17, 2017
Results First Posted : March 3, 2022
Last Update Posted : March 3, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Kidney, Autosomal Dominant | Behavioral: Weight Loss | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Investigator, Outcomes Assessor) |
Primary Purpose: | Other |
Official Title: | Daily Caloric Restriction and Intermittent Fasting in Overweight and Obese Adults With Autosomal Dominant Polycystic Kidney Disease |
Actual Study Start Date : | June 4, 2018 |
Actual Primary Completion Date : | October 13, 2020 |
Actual Study Completion Date : | October 13, 2020 |

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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Behavioral: Weight Loss
Weight loss behavioral intervention via one of two strategies. |
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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Behavioral: Weight Loss
Weight loss behavioral intervention via one of two strategies. |
- 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
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- Serum Insulin-like Growth Factor-1 Levels at Baseline [ Time Frame: Baseline ]Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group
- 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
- 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
- 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
- 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
- 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
- Change in PBMC Ratio of pS6K/s6K [ Time Frame: Baseline and 1 year ]Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group.
- 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
- Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI) [ Time Frame: Baseline and 1 year ]Percent change from baseline in height adjusted total kidney volume by MRI in each group

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342742
United States, Colorado | |
Kristen Nowak | |
Aurora, Colorado, United States, 80045 |
Principal Investigator: | Kristen Nowak, Ph.D., MPH | University of Colorado - Anschutz Medical Campus |
Documents provided by University of Colorado, Denver:
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT03342742 |
Other Study ID Numbers: |
17-1327 R03DK118215 ( U.S. NIH Grant/Contract ) |
First Posted: | November 17, 2017 Key Record Dates |
Results First Posted: | March 3, 2022 |
Last Update Posted: | March 3, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
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. |
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). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Arthrogryposis Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Overweight Urologic Diseases Body Weight Joint Diseases |
Musculoskeletal Diseases Muscular Diseases Musculoskeletal Abnormalities Congenital Abnormalities Kidney Diseases, Cystic Abnormalities, Multiple Ciliopathies Genetic Diseases, Inborn |