Abstract
OBJECTIVE
To investigate whether being “at-risk” for toilet and sanitation insecurity in the United States is associated with urinary symptoms, voiding behaviors, and psychosocial burden. Based on census data, nearly 2 million people in the United States do not have access to adequate plumbing. More may have inconsistent access related to cost, inadequate facilities for the number of people in a home, or declining regional infrastructure. The effects of inadequate access in the United States are poorly characterized.
METHODS
This is a secondary analysis of a community-based sample of adults electronically recruited to complete questionnaires on clinical and sociodemographic information, living situations, home toilets and plumbing, urinary symptoms, compensatory bladder behaviors, and psychosocial burden. Multivariable logistic regression was used to assess for associations between being at-risk for toilet and sanitation insecurity and urinary and psychosocial symptoms. Linear regression was used to assess for association with adopting compensatory bladder behaviors.
RESULTS
This sample included 4218 participants, of whom 17% were identified as being at-risk for toilet and sanitation insecurity. Being at-risk for toilet and sanitation insecurity was associated with worse overall urinary symptoms and greater bother from these symptoms, in addition to worse self-assessed mental and physical health, anxiety, stress, depression, and fewer social supports. Finally, those at-risk for toilet and sanitation insecurity were more likely to adopt burdensome and unhealthy compensatory bladder behaviors.
CONCLUSION
As with other social determinants of health, toilet and sanitation insecurity may be an under-appreciated contributor to urinary symptoms, unhealthy toileting behaviors, and psychosocial distress.
Access to clean water, working toilets, and sanitation is a global health issue. In 2010, the United Nations General Assembly recognized that access to safe and clean drinking water and sanitation is a human right and subsequently called for international efforts to improve access to these resources worldwide.1 The effects of toilet and sanitation insecurity on physical and mental health have been studied in resource-poor areas of the world; however, inadequate access to acceptable sanitation and water is a pressing issue for millions of people in the United States (U.S.).2
Few studies have examined toilet and sanitation insecurity in the U.S. in general, and there is even less literature examining the effect of this social risk factor on urinary symptoms and bladder health. Recently, the presence of overactive bladder (OAB) in U.S. adults was found to be associated with multiple unmet social needs, including lack of access to toilets, plumbing, and utilities in the home.3 Adult women with OAB are also more likely to exhibit “compensatory bladder behaviors” including delaying voiding, straining to void, and voiding only when convenient, in addition to adopting compensatory behaviors to help manage their urinary symptoms, including avoiding travel and social activities, decreasing physical activity, and planning of escape routes to access restrooms when in public.4,5 These behaviors are more common with increasing OAB severity and are associated with significant psychosocial burden, including increased anxiety and stress. Therefore, it seems likely that those without reliable access to toilets may adopt more unhealthy toileting behaviors due to this unmet need, which could ultimately have negative impacts on urinary symptoms, bladder health, and psychological health. These associations have not been fully elucidated in the literature. The objectives of this study were to identify associations between toilet and sanitation insecurity and urinary symptoms, compensatory bladder behaviors, and psychosocial burden in a sample of adults living in the U.S.
MATERIALS AND METHODS
Recruitment
This is a secondary analysis from an Institutional Review Board-approved (#211445) study on urinary symptoms and unmet social need.3 Between September 2021 and January 2022 a single email advertisement was used to recruit 5233 adults using ResearchMatch. Participants were incentivized with a chance to win $100 and went on to complete an anonymous online questionnaire using Research Electronic Data Capture (REDCap) Survey.6–8 Participants were ineligible if they were younger than 18 years old, did not finish the questionnaire, were pregnant, had a prior cystectomy, used a catheter or had a prior neurological disorder affecting their bladder, or reported currently living outside the U.S. The final sample included 4218 people, which is 81% of those recruited.
Data Collection
Participants self-reported sociodemographic information, which included age, gender identity, race/ethnicity, highest level of education, employment, living community, state of residence, type of insurance, household income, and other past medical and surgical history. The poverty rate was calculated according to the 2021 U.S. Poverty Guidelines. Regions of the U.S. were defined according to the U.S. Census Bureau.
Participants were asked about their home living situation, home ownership, sewage system and plumbing, and access to utilities. They were also asked about the number of and access to toilets at home and issues with access to reliable plumbing at home. “At-risk” for toilet and sanitation insecurity was defined as an answer of “Yes” to the question “Do you worry or stress about plumbing problems or toilets not working in your home?” or an answer more often than “Never” to the question “In the past month, how often were worried about having a place to urinate at home?” (answer options, “Never”, “Sometimes”, “Often”, “Always”).
Urinary symptoms were assessed using the Lower Urinary Tract Dysfunction Research Network 10-item Symptom Index (LURN SI-10), a validated measure assessing symptoms including urgency, frequency, incontinence, nocturia, bladder pain, voiding, post-micturition syndromes, and bother over a 7-day recall.9 To avoid redundant questions, questions 2 and 3 were combined. The total score was calculated according to scoring recommendations from 0 (least severe) to 38 (most severe).10 The final question regarding bother is not included in the final score and was assessed separately.
Psychosocial burden was assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item scales for anxiety, stress, and instrumental support and the 2-item assessments of mental and physical health (derived from the global health questionnaire).11 The PROMIS instruments are scored using item-level calibrations through the PROMIS Assessment Center Scoring Service. A T-score is standardized with a mean of 50, and a 10-point standard deviation calibrated to the general U.S. population. Because standardized scoring of the stress measure is not yet available in adults, the raw score was used. Depression was assessed with a single question to avoid redundancy. For anxiety, stress, and depression, higher scores represent more severe symptoms. For physical and mental health and instrumental support, higher scores indicate better health or support.
Compensatory bladder behaviors were assessed with 10 items from the OAB questionnaire HRQL (8 from the coping behaviors subscale and 2 from social subscale) and 2 additional questions asking about defensive voiding and limiting fluid intake. The OAB-q HRQL is assessed on a 6-point Likert scale (from “1, None of the time” to “6, All of the time”) over a 7-day recall.12 The 2 additional questions were assessed on a 5-point Likert scale. Responses to these items were summed and transformed to derive a scale (range 0–100) in a method consistent with prior studies, with a higher score representing greater burden and negative impact on quality of life.5 Individual behaviors were also dichotomized to “No” (ie, “None-”, “A little-”, “Some-”, or “A good bit of the time”) or “Yes” (ie, “Most-” or “All of the time”), to reflect habitual behavior.13
Statistical Analysis
Descriptive statistics were performed summarizing data as counts and percentages or means and standard deviations (or median and interquartile range). Multivariable logistic regression was used to assess association between being at-risk for toilet and sanitation insecurity and greater urinary symptoms assessed by LURN score and greater psychosocial burden as measured by the PROMIS instruments T-score or raw score, individually. The models were adjusted for the following covariates: age, body mass index (BMI), gender, race/ethnicity, type of living community, level of highest education, annual household income below the U.S. poverty guideline, employment status, type of insurance, type of home, home ownership, type of sewage system, and multiple comorbidities. Associations were expressed as odds ratios and 95% confidence intervals. Multivariable linear regression was used to examine associations between total compensatory bladder behavior scale and being at-risk for toilet insecurity, after adjusting for the above covariates, in addition to urinary symptom severity as measured by LURN score and greater psychosocial burden (as measured by PROMIS anxiety, stress, depression, support, and physical and mental health T-scores or raw scores). All analysis was performed in Stata 17.0 (StataCorp, College Station, TX) with a P-value of < .05 considered significant.
RESULTS
Of the 4218 participants, 508 (12%) answered “Yes” to the question “Do you worry or stress about plumbing problems or toilets not working in your home?” For the question “In the past month, how often were worried about having a place to urinate at home?” 350 (8%) answered more often than “Never.” According to the definition outlined above, 725 participants (17%) were at-risk for toilet and sanitation insecurity.
Baseline characteristics of those at-risk and not at-risk for toilet and sanitation insecurity are presented in Table 1. Comparison between the 2 groups revealed several differences, including in age, BMI, comorbid conditions, gender, race/ethnicity, educational attainment, employment, insurance status, and type of living community. Additionally, at-risk participants were less likely to be homeowners and more often utilized a septic sewage system. When we looked at the number of occupants in a home per home toilet, at-risk participants reported more occupants sharing 1 toilet. Table 2 presents data on urinary symptoms and psychosocial burdens. The presence of toilet and sanitation insecurity was associated with significantly higher mean urinary symptom and bother scores (ie, greater symptom severity), which remained significant after adjustment on multivariable logistic regression. This group also reported lower overall physical and mental health (ie, lower scores on the global physical and mental health measures), more severe symptoms (ie, higher score) of anxiety, stress, and depression, and less social support (indicated by lower scores on the instrumental support measure). All associations remained consistent on multivariable logistic regression analysis, except for depression, which was inversely associated after adjusting for covariates (OR 0.86, 95% CI 0.77–0.96, P = .009), and the mental health global score, which was no longer significant.
Table 1.
Baseline sociodemographic characteristics of participants at-risk for toilet and sanitation insecurity and those not at-risk.
| At-risk (%) | Not at-risk (%) | P-value | |
|---|---|---|---|
| No. | 725 (17.2) | 3493 (82.8) | |
| Mean age (y [SD])* | 45.1 (16.0) | 49.9 (17.5) | < .001 |
| Mean BMI (kg/m^2 [SD])* | 28.5 (7.4) | 27.5 (6.6) | < .001 |
| Gender* | < .001 | ||
| Male | 138 (19.0) | 752 (21.5) | |
| Female | 550 (75.9) | 2673 (76.5) | |
| Transgender/non-binary | 36 (5.0) | 61 (1.8) | |
| Unspecified | 1 (0.1) | 7 (0.2) | |
| Race/ethnicity* | < .001 | ||
| White, non-Hispanic | 565 (77.9) | 2980 (85.3) | |
| Black, non-Hispanic | 47 (6.5) | 166 (4.8) | |
| All Hispanic | 28 (3.9) | 121 (3.5) | |
| Asian | 29 (4.0) | 106 (3.0) | |
| Multiracial | 25 (3.5) | 71 (2.0) | |
| Other | 24 (3.3) | 29 (0.8) | |
| Unspecified | 7 (1.0) | 20 (0.6) | |
| Type of living community* | .004 | ||
| Rural area | 112 (15.5) | 406 (11.6) | |
| Small town/city | 183 (25.2) | 914 (26.2) | |
| Suburban | 241 (33.2) | 1346 (38.5) | |
| Urban/large city | 189 (26.1) | 827 (23.7) | |
| Region of U.S. | .190 | ||
| Northeast | 125 (17.2) | 542 (15.5) | |
| Midwest | 208 (28.7) | 911 (26.1) | |
| South | 261 (36.0) | 1338 (38.3) | |
| West | 131 (18.1) | 702 (20.1) | |
| Education level* | < .001 | ||
| High school diploma or less | 173 (23.7) | 538 (15.4) | |
| Associate’s or Bachelor’s degree | 326 (45.0) | 1546 (44.3) | |
| Graduate or professional degree | 226 (31.2) | 1409 (40.3) | |
| < U.S. 2021 poverty guideline* | 90 (12.4) | 140 (4.0) | < .001 |
| Employment status* | < .001 | ||
| Working full time | 313 (43.2) | 1623 (46.5) | |
| Working part time | 111 (15.3) | 416 (11.9) | |
| Unemployed | 66 (9.1) | 171 (4.9) | |
| Retired | 90 (12.4) | 882 (25.3) | |
| Disability | 95 (13.1) | 205 (5.9) | |
| Other | 50 (6.9) | 196 (5.6) | |
| Health insurance* | < .001 | ||
| Uninsured | 66 (9.1) | 208 (6.0) | |
| Medicaid | 86 (11.9) | 206 (5.9) | |
| Medicare | 78 (10.8) | 444 (12.7) | |
| Private | 344 (47.5) | 1942 (55.6) | |
| Medicaid/Medicare + Private | 53 (7.3) | 373 (10.7) | |
| Military | 11 (1.5) | 55 (1.6) | |
| Other | 87 (12.0) | 265 (7.6) | |
| Home type* | .001 | ||
| Single-family home | 495 (68.3) | 2449 (70.1) | |
| Apartment, condo, complex | 186 (25.7) | 930 (26.6) | |
| Mobile home, trailer, or other | 44 (6.1) | 114 (3.3) | |
| Home ownership* | < .001 | ||
| Owned | 399 (55.0) | 2341 (67.0) | |
| Rented | 281 (38.8) | 1062 (30.4) | |
| Other arrangement | 45 (6.2) | 90 (2.6) | |
| Sewage system type* | < .001 | ||
| Public sewer | 467 (64.4) | 2601 (74.5) | |
| Septic system | 156 (21.5) | 577 (16.5) | |
| Unknown/Other | 102 (14.1) | 315 (9.0) | |
| Problems with plumbing in past 3 mo (%) | 332 (45.8) | 385 (11.0) | < .001 |
| Problems with sewage in past 3 mo (%) | 156 (21.5) | 131 (3.8) | < .001 |
| Fear of utilities being shut off in past 3 mo (%) | 90 (12.4) | 98 (2.8) | < .001 |
| # Occupants per home toilet (%) | < .001 | ||
| < 1 | 127 (17.5) | 1048 (30.0) | |
| 1 | 315 (43.5) | 1824 (52.2) | |
| 2 | 169 (23.3) | 491 (14.1) | |
| 3 | 70 (9.7) | 91 (2.6) | |
| 4 + | 44 (6.1) | 39 (1.1) | |
| Comorbid condition | |||
| Diabetes* | 90 (12.4) | 297 (8.5) | .001 |
| Cardiovascular disease | 43 (5.9) | 222 (6.4) | .67 |
| Hypertension* | 232 (32.0) | 920 (26.3) | .002 |
| Irritable bowel syndrome* | 139 (19.2) | 473 (13.5) | < .001 |
| Regularly requiring assistance with mobility* | 79 (10.9) | 240 (6.9) | < .001 |
Indicates covariates in multivariable model, presented in Table 2
Table 2.
Comparison of urinary symptoms and psychosocial burden between those at-risk for toilet and sanitation insecurity and those not at-risk.
| At-risk | Not at-risk | P-value | Adjusted OR (95% CI) | P-value | |
|---|---|---|---|---|---|
| Mean LURN SI-10 score (SD) | 8.5 (5.5) | 6.2 (4.2) | < .001 | 1.06 (1.05–1.09) | < .001 |
| LURN symptom bother | < .001 | ||||
| Not at all | 225 (31.0) | 1968 (56.3) | |||
| Somewhat | 381 (52.6) | 1301 (37.3) | |||
| Very | 80 (11.0) | 176 (5.0) | |||
| Extremely | 39 (5.4) | 48 (1.4) | |||
| Mean PROMIS Physical Health 2a Tscore (SD) | 45.3 (8.8) | 49.9 (8.2) | < .001 | 0.98 (0.97–0.99) | .019 |
| Mean PROMIS Mental Health 2a Tscore (SD) | 42.9 (8.9) | 48.5 (8.9) | < .001 | 0.99 (0.98–1.01) | .89 |
| Mean PROMIS Anxiety 4a Tscore (SD) | 59.6 (9.0) | 52.8 (9.1) | < .001 | 1.03 (1.01–1.04) | .002 |
| Mean PROMIS Stress 4a Tscore (SD) | 61.8 (8.6) | 54.4 (9.3) | < .001 | 1.06 (1.04–1.08) | < .001 |
| Mean PROMIS Depression 4a raw score (SD) | 2.7 (1.2) | 2.1 (1.1) | < .001 | 0.86 (0.77–0.96) | .009 |
| Mean PROMIS Instrumental Support 4a Tscore (SD) | 47.9 (9.8) | 52.1 (10.4) | < .001 | 0.98 (0.97–0.99) | .001 |
Adjusted odds ratios and 95% confidence interval for associations between worse symptom score and greater psychosocial burden as assessed by PROMIS instrument scores. Model-adjusted covariates indicated in Table 1 (*)
Participants at-risk for toilet and sanitation insecurity were also more likely to report greater use of all compensatory bladder behaviors (Table 3). At-risk participants had higher overall compensatory bladder scale scores, and this difference remained significant on linear regression modeling (beta coefficient 4.0, 95% CI 3.0–5.1, P < .001) after adjusting for covariates.
Table 3.
Comparison between compensatory bladder behaviors in participants at-risk for toilet and sanitation insecurity and those not at-risk.
| At-risk (%) | Not at-risk (%) | P-value | |
|---|---|---|---|
| Median compensatory bladder scale (IQR) | 13.8 (5.2, 29.3) | 5.2 (1.7, 12.1) | < .001 |
| Carefully plan commute | 80 (11.0) | 137 (3.9) | < .001 |
| Plan “escape routes” in public | 70 (9.7) | 105 (3.0) | < .001 |
| Decrease physical activities | 34 (4.7) | 55 (1.6) | < .001 |
| Avoid activities away from restrooms | 62 (8.6) | 84 (2.4) | < .001 |
| Adjust travel plans | 67 (9.2) | 90 (2.6) | < .001 |
| Locate restroom upon arrival to new place | 104 (14.3) | 189 (5.4) | < .001 |
| Plan activities more carefully | 74 (10.2) | 107 (3.1) | < .001 |
| Uncomfortable when traveling with others | 66 (9.1) | 68 (2.0) | < .001 |
| Stay home more often | 46 (6.3) | 51 (1.5) | < .001 |
| Decrease social gatherings | 37 (5.1) | 33 (0.9) | < .001 |
| Defensive voiding | 243 (33.5) | 596 (17.1) | < .001 |
| Limit fluid intake | 88 (12.1) | 206 (5.9) | < .001 |
Number and percentages for individual behaviors represent those who reported “Most of time” or “Always” doing a behavior in the past 7 days
DISCUSSION
In this nationwide sample of U.S. adults, 17% were at-risk for toilet and sanitation insecurity. Even after adjusting for various covariates associated with this at-risk population, there remained important associations between being at-risk and more severe urinary symptoms and greater psychosocial symptoms, including anxiety and stress, less social supports, and overall worse self-perceived physical health. Those at-risk also more frequently reported adopting burdensome and unhealthy bladder behaviors, which could ultimately have further negative impacts on bladder and psychosocial health.
Multiple studies have examined the unique physical, social, and mental health challenges that residents in low-income and low-resource countries, particularly women, face in the settings of toilet and sanitation insecurity, such as open urination/defecation or remote locations of available toilets, including threats to safety and dignity when having to use community facilities or facilities at night or in unsafe areas.14,15 These challenges may then provoke unhealthy bladder behaviors, such as food and fluid deprivation and delayed voiding to cope with lack of access to safe and reliable sanitation and contribute to significant psychosocial burdens, particularly in women.14,16–22
The present study is one of the first to examine home toilet and sanitation insecurity in the U.S. to further understand this population and potential impact to bladder health and symptoms. There were several sociodemographics associated with the at-risk population in this cohort, which are consistent with the literature. Previous studies have found race and ethnicity are strong predictors of water access issues in the U.S., a relationship which was also observed in the present cohort.2 Socioeconomic status and household income have been associated with poorer access to complete plumbing,23 however, this is not uniformly true, which highlights the multifactorial and complicated nature of these relationships.24 Living in very rural or urban areas, or relying on septic sewage systems were also more common in the at-risk group in our study, which is again consistent with prior literature demonstrating strong correlations between rurality, poverty, and poor sanitation access.23 Finally, and particularly interesting, is the association observed in the present study between those at-risk for home toilet and sanitation insecurity and having more occupants per toilet in the home. To our knowledge, this is first analysis of this kind in the U.S. Globally, shared sanitation between 2 or more house-holds is a common strategy to facilitate access to sanitation for residents who would otherwise lack these services. The literature examining shared sanitation has demonstrated that an increased number of users and even the relationships between these users, can contribute to lower levels of cleanliness, disagreements among users, varying lack of ownership regarding latrine maintenance, and individual avoidance of using the shared toilet.25 We believe sharing a toilet among more occupants of a home regardless of sanitation type could contribute to similar phenomena, and it seems logical that this would be associated with individual toilet insecurity in the home. Further examining the experiences of those with higher occupants per toilet may be interesting for future research.
In the present study in the U.S., we demonstrate that participants who are at-risk for toilet and sanitation insecurity have more severe urinary symptoms, even when controlling for other covariates. This is one of the first studies to examine the impact of decreased access to toilets and sanitation in the home on urologic outcomes. A recent prospective study examined associations between specific social needs and severity of OAB in adult women living near an urban medical center, and found that food insecurity, healthcare costs, difficulty concentrating, and difficulty finding or keeping employment were significantly associated with increasing OAB severity.26 Additionally, a study of community-based adults found associations between multiple common urinary conditions (including OAB, incontinence, and recurrent urinary tract infections) and severity of urinary symptoms with an increasing number of unmet social needs.27 Finally, another survey-based study looked specifically at associations between OAB in community-dwelling men and women and a wide variety of unmet social needs.3 In this cohort, OAB was associated with fear of losing utilities, and lack of available and working toilets and plumbing in the home, even after adjusting for multiple covariates.
We also observed an association between being at-risk for toilet and sanitation insecurity and an increased burden of psychosocial symptoms, including anxiety and stress. Numerous studies link social determinants to mental health.28 More specifically, lack of household water and sanitation has been associated with increased risk of mental health disorders in the global and public health literature.22 In fact, the psychosocial impacts of a lack of water, toilets, and sanitation, particularly in women, have been very well-documented throughout numerous qualitative studies in low-income countries.17–20 Despite our knowledge regarding multiple social risk factors on mental health conditions in the U.S., there is a paucity of data on the psychosocial impact particularly of toilet, sanitation, and water access issues.
Finally, in our study, we observed that people who were at-risk for toilet and sanitation insecurity utilized more compensatory bladder behaviors. Other studies have shown that these behaviors are adopted by women with urologic issues, including OAB, and are associated with greater urinary symptom severity and increased stress and anxiety.5 Lack of privacy, satisfactory or clean toilets, or restrictions by employers are associated with increased prevalence of urinary urgency, incontinence, and infrequent voiding.29 There is a paucity of literature on coping behaviors specifically in men with LUTS, but the qualitative data that exists suggests that men who tend to limit activities out of the home or socially isolate leads to feelings of embarrassment and shame.30 In one large population-based study on male LUTS and types of coping strategies, authors demonstrated that using active problem-solving coping, over passive or avoidant, can improve QOL even without an improvement in LUTS severity.31 Compensatory bladder behaviors have been examined in the context of toilet and sanitation insecurity in the global health literature.14 Women in India were 3 times more likely to exhibit delayed voiding when they perceived a community toilet to be unsafe.16 In the present study, even when controlling for urinary and psychosocial symptom severity, there was an association between toilet and sanitation insecurity and all compensatory bladder behaviors assessed, suggesting lack of access to reliable toilets and sanitation can reinforce these unhealthy behaviors.
There are a number of limitations to our study. There are inherent limitations to self-reported symptoms in an online questionnaire-based design which may introduce recall bias, although we used validated questionnaires whenever possible to limit this effect. The use of ResearchMatch to recruit participants introduces selection bias. Most patients in the study population were white, non-Hispanic, female, educated, employed, and had the ability to respond to an email advertisement and complete the questionnaire electronically. Thus, the results are not generalizable to the U.S. population. However, it is meaningful that we were still able to find a significant proportion of this relatively homogeneous study population who were at-risk for toilet and sanitation insecurity. Further studies in the most vulnerable and at-risk populations of the U.S. are needed to more completely understand the magnitude of the associations presented in this study. Finally, due to the cross-sectional design, the associations observed here do not confer causality. The relationships here are complex and bi-directional, or circular, in nature, and cannot be completely understood based on the findings of this study alone.
Despite these limitations, the present study is the first and largest study to date looking at toilet and sanitation insecurity in the U.S. and its associations to urinary symptoms, mental health, and unhealthy voiding behaviors. As with other social determinants of health and social risk factors, toilet and sanitation insecurity may be an under-appreciated contributor to chronic medical conditions, including bladder health, urinary symptoms, and psychosocial distress. Further investigations on particularly vulnerable populations are needed to understand the magnitude of these effects and pathways involved in these complex relationships to identify areas for intervention.
CONCLUSION
In this large sample of adults living in the U.S, we demonstrate associations between being at-risk for toilet and sanitation insecurity and severity of urinary symptoms and the adoption of unhealthy bladder habits, which may have implications on bladder health. Those at-risk also had more severe psychosocial burden, with more severe stress and anxiety, even when adjusting for multiple covariates. In doing this investigation, we hope to draw attention to this problem that affects millions of residents of the U.S., and demonstrate the negative impacts lack of toilets, water, and sanitation can have on urinary symptoms, bladder health, and mental health. Importantly, we also hope this study generates hypotheses to fuel research on this topic for the future.
Declaration of Competing Interest
Dr. W Stuart Reynolds—source of funding: Grants UL1 TR000445 from NCATS/NIH and R01DK128293 and R01DK129624 from NIDDK; the remaining authors declare that they have no conflict of interest. Institutional Review Board-approved: Study #211445.
Funding by Grants UL1 TR000445 from NCATS/NIH and R01DK128293 and R01DK129624 from NIDDK (WSR)
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