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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK118215 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Caloric Restriction | Experimental | 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. |
|
| Intermittent Fasting | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weight Loss | Behavioral | Weight loss behavioral intervention via one of two strategies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility to Enroll and Retain Participants | Numbers of individuals pre-screened | Through study completion, an expected duration of 18 months |
| Feasibility to Enroll Participants | Numbers of individuals screened | Through study completion, an expected duration of 18 months |
| Feasibility to Retain Participants | Numbers of individuals enrolled | Through study completion, an expected duration of 18 months |
| Feasibility to Retain Participants | Numbers of individuals retained | Through study completion, an expected duration of 18 months |
| Percent Change From Baseline Body Weight (Weight Loss) | Measurement of body weight pre to post intervention in each group | Baseline, 12 weeks, and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability, Measured as Adverse Events | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristen Nowak, Ph.D., MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kristen Nowak | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39356039 | Derived | 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. |
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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.
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 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).
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One participant dropped out prior to randomization. This individual is included in the protocol enrollment number, but not the number of participants started.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Weight Loss: Weight loss behavioral intervention via one of two strategies. |
| FG001 | 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). Weight Loss: Weight loss behavioral intervention via one of two strategies. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Weight Loss: Weight loss behavioral intervention via one of two strategies. |
| BG001 | Intermittent Fasting |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility to Enroll and Retain Participants | Numbers of individuals pre-screened | Posted | Count of Participants | Participants | Through study completion, an expected duration of 18 months |
|
|
1 Year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Weight Loss: Weight loss behavioral intervention via one of two strategies. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hunger | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Nowak | University of Colorado Denver | Anschutz | 303-724-1111 | clinicalresearchsupportcenter@ucdenver.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 20, 2020 | Dec 17, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 16, 2020 | Dec 17, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016891 | Polycystic Kidney, Autosomal Dominant |
| ID | Term |
|---|---|
| D007690 | Polycystic Kidney Diseases |
| D052177 | Kidney Diseases, Cystic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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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 | 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 | 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 | 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 | 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 | 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 | Self-reported energy intake | Baseline, 12 weeks and 1 year |
| Change in Macronutrient Intake | Self-reported macronutrient intake | Baseline, 12 weeks and 1 year |
| Serum Insulin-like Growth Factor-1 Levels at Baseline | Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group | Baseline |
| Serum Insulin-like Growth Factor-1 Levels at 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 | 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 | 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 | 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 | 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 | Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group. | Baseline and 1 year |
| Change in PBMC pAMPK/AMPK Expression | 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) | Percent change from baseline in height adjusted total kidney volume by MRI in each group | Baseline and 1 year |
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). Weight Loss: Weight loss behavioral intervention via one of two strategies. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| CKD-EPI eGFR | Estimated glomerular filtration rate by the Chronic Kidney Disease Epidemiology Collaboration equation. This estimates kidney function. scores of about 90 are normal, where as scores below 60 may indicate kidney disease. | Mean | Standard Deviation | ml/minute/1.73m^2 |
|
| Total Kidney Volume by Magnetic Resonance Imaging (MRI) | Height adjusted total kidney volume at baseline by MRI in each group. | This baseline measure could not be collected for all participants. | Median | Inter-Quartile Range | ml/m |
|
|
| Primary | Feasibility to Enroll Participants | Numbers of individuals screened | Posted | Count of Participants | Participants | Through study completion, an expected duration of 18 months |
|
|
|
| Primary | Feasibility to Retain Participants | Numbers of individuals enrolled | Posted | Count of Participants | Participants | Through study completion, an expected duration of 18 months |
|
|
|
| Primary | Feasibility to Retain Participants | Numbers of individuals retained | Posted | Count of Participants | Participants | Through study completion, an expected duration of 18 months |
|
|
|
| Primary | Percent Change From Baseline Body Weight (Weight Loss) | Measurement of body weight pre to post intervention in each group | This outcome measure could not be collected for some participants. | Posted | Mean | Standard Deviation | Percent change in weight | Baseline, 12 weeks, and 1 year |
|
|
|
| Secondary | Safety and Tolerability, Measured as Adverse Events | Number of participants with treatment-related adverse events in each group as evaluated by monthly phone questionnaire | Posted | Number | Number of participants w/ adverse events | 1 year |
|
|
|
| Secondary | Quality of Life Scores at 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Quality of Life Scores at 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. | This outcome measure could not be collected for some participants. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Quality of Life Scores at 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. | This outcome measure could not be collected for some participants. | Posted | Mean | Standard Deviation | score on a scale | 1 Year |
|
|
|
| Secondary | Mood at 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Mood at 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. | This outcome measure could not be collected for some participants. | Posted | Mean | Standard Deviation | score on a scale | 12 Weeks |
|
|
|
| Secondary | Mood at 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. | This outcome measure was not collected for some participants. | Posted | Mean | Standard Deviation | score on a scale | 1 Year |
|
|
|
| Secondary | Change in Energy Intake | Self-reported energy intake | This outcome is not reported because the data were not collected. | Posted | Baseline, 12 weeks and 1 year |
|
|
| Secondary | Change in Macronutrient Intake | Self-reported macronutrient intake | This outcome is not reported because the data were not collected. | Posted | Baseline, 12 weeks and 1 year |
|
|
| Secondary | Serum Insulin-like Growth Factor-1 Levels at Baseline | Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group | Posted | Mean | Standard Deviation | ng/ml | Baseline |
|
|
|
| Secondary | Serum Insulin-like Growth Factor-1 Levels at 12 Weeks | Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group | This outcome measure could not be collected for some participants. | Posted | Mean | Standard Deviation | ng/ml | 12 Weeks |
|
|
|
| Secondary | Serum Insulin-like Growth Factor-1 Levels at 1 Year | Serum insulin-like growth factor-1 (IGF-1) levels will be evaluated in each group | This outcome measure could not be collected for some participants. | Posted | Mean | Standard Deviation | ng/ml | 1 Year |
|
|
|
| Secondary | Insulin-like Growth Factor Binding Protein-1 Levels at Baseline | Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group | Posted | Median | Inter-Quartile Range | ng/ml | Baseline |
|
|
|
| Secondary | Insulin-like Growth Factor Binding Protein-1 Levels at 12 Weeks | Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group | This outcome measure could not be collected for some participants. | Posted | Median | Inter-Quartile Range | ng/ml | 12 Weeks |
|
|
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| Secondary | Insulin-like Growth Factor Binding Protein-1 Levels at 1 Year | Insulin-like growth factor binding protein-1 (IGFBP-1) levels will be evaluated in each group | This outcome measure could not be collected for some participants. | Posted | Median | Inter-Quartile Range | ng/ml | 1 Year |
|
|
|
| Secondary | Change in PBMC Ratio of pS6K/s6K | Ratio of protein expression of phosphorylated S6K to S6K peripheral blood mononuclear cell protein expression of S6 kinase (S6K) in each group. | Not all participants could be analyzed for this outcome measure | Posted | Mean | Standard Deviation | ratio | Baseline and 1 year |
|
|
|
| Secondary | Change in PBMC pAMPK/AMPK Expression | Ratio of peripheral blood mononuclear cell protein expression of phosphorylated AMP-activated kinase (AMPK) to AMPK in each group | Posted | Mean | Standard Deviation | ratio | Baseline and 1 year |
|
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| Secondary | Percent Change in Total Kidney Volume by Magnetic Resonance Imaging (MRI) | Percent change from baseline in height adjusted total kidney volume by MRI in each group | Not all participants could be analyzed for this outcome measure | Posted | Mean | Standard Deviation | Percent change | Baseline and 1 year |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 10 |
| 15 |
| EG001 | 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). Weight Loss: Weight loss behavioral intervention via one of two strategies. | 0 | 13 | 0 | 13 | 13 | 13 |
| Gastrointestinal distress | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Lightheadedness/dizziness | General disorders | Systematic Assessment |
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| Cold Intolerance | General disorders | Systematic Assessment |
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| Change in mood | Psychiatric disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Impaired concentration and/or cognitive difficulties | Psychiatric disorders | Systematic Assessment |
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| Tremor | Nervous system disorders | Systematic Assessment |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000072661 | Ciliopathies |
| D030342 | Genetic Diseases, Inborn |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 Year |
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