<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03244189</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00083271</org_study_id>
    <secondary_id>1U01DK110988</secondary_id>
    <nct_id>NCT03244189</nct_id>
  </id_info>
  <brief_title>Prevention of Urinary Stones With Hydration</brief_title>
  <acronym>PUSH</acronym>
  <official_title>Prevention of Urinary Stones With Hydration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized clinical trial to investigate the impact of increased fluid intake and increased&#xD;
      urine output on the recurrence rate of urinary stone disease (USD) in adults and children.&#xD;
      The primary aim of the trial is to determine whether a multi-component program of behavioral&#xD;
      interventions to increase fluid intake will result in reduced risk of stone disease&#xD;
      progression over a 2-year period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two arm randomized controlled trial that incorporates pragmatic features, an&#xD;
      adaptable intervention, patient choice, and remote monitoring of fluid intake through a&#xD;
      &quot;smart&quot; water bottle. The study period is 24 months and will enroll approximately 1642&#xD;
      participants. Randomization will be stratified within a study site by age (adult vs.&#xD;
      adolescent) and first time vs. recurrent stone former.&#xD;
&#xD;
      Intervention and control arm study participants will receive a smart water bottle that&#xD;
      records daily fluid consumption, usual care including guideline-based recommendations of&#xD;
      adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine&#xD;
      collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 4, 2017</start_date>
  <completion_date type="Anticipated">May 13, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 13, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stone passage observed and/or captured by the study participant.</measure>
    <time_frame>From Baseline through 24 months.</time_frame>
    <description>Will be measured by the time from Baseline to the passage of 1 or more stones by a participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Procedural intervention for symptomatic stone</measure>
    <time_frame>From Baseline through 24 months.</time_frame>
    <description>From Baseline through 24 months; will be measured by the time from Baseline to a procedure to remove a symptomatic stone by a participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any procedural intervention for removal of asymptomatic renal or ureteral stone</measure>
    <time_frame>From Baseline through 24 months.</time_frame>
    <description>Will be measured by the time from Baseline to a procedure to remove an asymptomatic stone by a participant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Asymptomatic formation of new stone detected by imaging</measure>
    <time_frame>From Baseline through 24 months.</time_frame>
    <description>Will be measured by the time from Baseline to the formation of an asymptomatic stone by a participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth of existing stone by ≥ 2 mm in any dimension detected by imaging</measure>
    <time_frame>From Baseline through 24 months.</time_frame>
    <description>Comparison of the size of any stone on first observation versus later observations or at passage. Will be measured primarily through imaging (CT scan or ultrasound).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite outcome: symptomatic stone recurrence, asymptomatic stone formation, increase of existing stone by ≥2 mm in any dimension detected by imaging</measure>
    <time_frame>From Baseline through 24 months.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 hour urine total volume</measure>
    <time_frame>From Baseline through 24 months.</time_frame>
    <description>Will measure and compare 24 hour urine volumes from screening through 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs of study interventions and treatments for USD during the follow-up period</measure>
    <time_frame>Compared total between Baseline and the Month 24 visit.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of lower urinary tract symptoms (Comprehensive Assessment of Self-reported Urinary Symptoms)</measure>
    <time_frame>From Baseline through the Month 24 visit.</time_frame>
    <description>Will compare the results of the CASUS questionnaires completed throughout the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1658</enrollment>
  <condition>Urinary Stones</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention arm will receive an individualized &quot;fluid prescription&quot;, which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control arm will receive standard care instructions according to American Urological Association (AUA) guidelines to increase overall fluid consumption to achieve study-specified urine output. They will also receive a &quot;smart&quot; water bottle with capability to self-monitor their fluid intake.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fluid prescription</intervention_name>
    <description>The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial incentive</intervention_name>
    <description>Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Structured Problem Solving</intervention_name>
    <description>Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged ≥ 12 years&#xD;
&#xD;
          2. At least 1 symptomatic stone event (passage or procedural intervention) within 3 years&#xD;
             prior to enrollment or a symptomatic stone event within 5 years if the patient also&#xD;
             has new stone formation detected on imaging during the last 5 years. Symptomatic stone&#xD;
             defined as any of the following:&#xD;
&#xD;
               1. Stone passage&#xD;
&#xD;
               2. Procedural intervention&#xD;
&#xD;
               3. Radiographically or ultrasonographically confirmed stone with any of the&#xD;
                  following:&#xD;
&#xD;
             i. Gross hematuria ii. Renal colic or atypical abdominal pain attributed to the stone,&#xD;
             as determined by a treating provider iii. A clinical pattern of intermittent symptoms&#xD;
             consistent with intermittent obstruction at the ureteropelvic junction, as determined&#xD;
             by a treating provider&#xD;
&#xD;
          3. Low 24-hr urine volume&#xD;
&#xD;
               1. ≥18 years old: &lt;2.0 L/day&#xD;
&#xD;
               2. &lt;18 years old: &lt;25 ml/Kg/day up to 2.0L/day&#xD;
&#xD;
          4. Able to provide informed consent (parental permission for children)&#xD;
&#xD;
          5. Owning and willing to use a smartphone or other device (e.g., tablet) compatible with&#xD;
             the study-provided wireless enabled &quot;smart&quot; bottle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Spinal cord injury&#xD;
&#xD;
          2. Currently undergoing active treatment for cancer except basal cell skin cancer, or&#xD;
             patients with a history of cancer who completed their initial therapy &lt;1 year before&#xD;
             screening.&#xD;
&#xD;
          3. Known infectious (struvite), monogenic or other causes of stone disease for which&#xD;
             therapies are likely to significantly alter course of stone disease&#xD;
&#xD;
               1. Cystinuria&#xD;
&#xD;
               2. Primary hyperoxaluria&#xD;
&#xD;
               3. Primary xanthinuria&#xD;
&#xD;
               4. Primary hyperparathyroidism&#xD;
&#xD;
               5. Sarcoidosis&#xD;
&#xD;
               6. Medullary sponge kidney&#xD;
&#xD;
          4. History or presence of hyponatremia (serum sodium &lt;130 mmol/L) or hypo-osmolality&#xD;
             (serum osmolality &lt;275 mosm/kg)&#xD;
&#xD;
          5. Study participants with comorbidities that preclude high fluid intake or prior surgery&#xD;
             precluding high fluid intake or leading to GI fluid losses&#xD;
&#xD;
               1. History of or current Crohn's disease, ulcerative colitis, short gut syndrome&#xD;
                  (e.g. ileostomy, bowel bypass surgery to treat obesity, small bowel resection),&#xD;
                  chronic diarrhea, or GI tract ostomy.&#xD;
&#xD;
               2. History of malabsorptive (e.g., Roux-en-Y gastric bypass) or restrictive (e.g.,&#xD;
                  sleeve gastrectomy) bariatric surgery procedures&#xD;
&#xD;
               3. Congestive heart failure&#xD;
&#xD;
             i. NYHA class II or greater, and/or ii. Hospital admission in the past year for heart&#xD;
             failure d. Lung disease with a home oxygen requirement e. Chronic kidney disease (eGFR&#xD;
             &lt;30 ml/min/1.7 m2 over a 3-month period) i. For adults (age ≥18), we will use the&#xD;
             CKD-Epi equation which requires the measurement of serum creatinine only. ii. For&#xD;
             children (age &lt;18), we will use the bedside Schwartz (CKiD) formula. f. Nephrotic&#xD;
             syndrome (&gt;3.5 grams of protein per 24 hours) g. Cirrhosis with ascites&#xD;
&#xD;
          6. Women who are currently pregnant or planning pregnancy within 2 years.&#xD;
&#xD;
          7. Renal transplant recipient&#xD;
&#xD;
          8. Bedridden study participants (ECOG ≥ 3)&#xD;
&#xD;
          9. Uncorrected anatomical obstruction of the urinary tract&#xD;
&#xD;
         10. History of recurrent urinary tract infections (&gt; 3 UTI/year proven by urine culture)&#xD;
&#xD;
         11. Exclusions due to medication use:&#xD;
&#xD;
               1. Chronic use of lithium&#xD;
&#xD;
               2. Long-term glucocorticoid use (&gt; 7.5 mg prednisone daily for &gt; 30 days prior to&#xD;
                  enrollment)&#xD;
&#xD;
               3. Intake of narcotic medication on a daily basis for &gt;30 days prior to enrollment&#xD;
&#xD;
               4. Supplemental Vitamin C (&gt; 1 g daily)&#xD;
&#xD;
         12. Individuals with stones that have developed after the initiation of medications that&#xD;
             are strongly associated with USD such as carbonic anhydrase inhibitors (acetazolamide,&#xD;
             topiramate, zonisamide), high dose vitamin C (&gt; 1 g daily), high dose calcium&#xD;
             supplementation (&gt; 1,200 mg daily) AND who have discontinued or plan to discontinue&#xD;
             these medications.&#xD;
&#xD;
         13. Individuals with stones composed of medications that may crystallize in the urine&#xD;
             (guaifenesin, sulfonamides, triamterene, and the protease inhibitors indinavir and&#xD;
             nelfinavir) AND who have discontinued or plan to discontinue these medications.&#xD;
&#xD;
             Note: Individuals who are on long-term medications that increase the risk of stone&#xD;
             disease, who cannot stop these medications due to other chronic conditions (e.g., HIV)&#xD;
             and who may reduce their risk for stone recurrence through increased fluid intake,&#xD;
             will be eligible to participate in the trial. Examples of these medications include:&#xD;
&#xD;
               1. Carbonic anhydrase inhibitors (acetazolamide, topiramate, zonisamide)&#xD;
&#xD;
               2. Medications that may crystallize in the urine (guaifenesin, sulfonamides,&#xD;
                  triamterene, and the protease inhibitors indinavir and nelfinavir).&#xD;
&#xD;
         14. Study participants &lt;2 yrs life expectancy&#xD;
&#xD;
         15. Non-English Speakers&#xD;
&#xD;
         16. History of Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)&#xD;
&#xD;
         17. Anatomical urologic abnormalities including ileal conduits, horseshoe kidney,&#xD;
             megaureter or solitary kidney.&#xD;
&#xD;
         18. Psychiatric conditions impairing compliance with the study&#xD;
&#xD;
         19. Vulnerable population (prisoner and/or cognitive impairment that the investigator&#xD;
             feels will impact the study participant's ability to participate in the protocol)&#xD;
&#xD;
         20. Individual who will be unable to participate in the protocol in the judgment of the&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Scales, MD, MSHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University, St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://usdrn.org/</url>
    <description>The Urinary Stone Disease Research Network (USDRN) website. The USDRN is the program conducting the PUSH study.</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>November 10, 2022</last_update_submitted>
  <last_update_submitted_qc>November 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urinary Stone Disease</keyword>
  <keyword>Kidney Stone</keyword>
  <keyword>Urinary Calculi</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Calculi</mesh_term>
    <mesh_term>Urolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data and samples, for subjects who consent to sharing, will be sent to the NIDDK Data and Biological Samples Repository following database lock.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>2 years after the last visit of the last participant randomized.</ipd_time_frame>
    <ipd_access_criteria>Anyone with access to the NIDDK Data and Biological Samples Repository</ipd_access_criteria>
    <ipd_url>https://repository.niddk.nih.gov/home/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03244189
org study id: Pro00083271
secondary id: 1U01DK110988
nct id: NCT03244189
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A randomized clinical trial to investigate the impact of increased fluid intake and increased
      urine output on the recurrence rate of urinary stone disease (USD) in adults and children.
      The primary aim of the trial is to determine whether a multi-component program of behavioral
      interventions to increase fluid intake will result in reduced risk of stone disease
      progression over a 2-year period.
This is a two arm randomized controlled trial that incorporates pragmatic features, an
      adaptable intervention, patient choice, and remote monitoring of fluid intake through a
      "smart" water bottle. The study period is 24 months and will enroll approximately 1642
      participants. Randomization will be stratified within a study site by age (adult vs.
      adolescent) and first time vs. recurrent stone former.

      Intervention and control arm study participants will receive a smart water bottle that
      records daily fluid consumption, usual care including guideline-based recommendations of
      adequate fluid intake to decrease kidney stone recurrence, and periodic 24 hour urine
      collections, imaging (low-dose CT scan or ultrasound) and follow-up questionnaires.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
masking description: The Principal Investigator and site investigators, along with the primary study statistician will remind blinded throughout the trial.
measure: Stone passage observed and/or captured by the study participant.
time frame: From Baseline through 24 months.
description: Will be measured by the time from Baseline to the passage of 1 or more stones by a participant.
measure: Procedural intervention for symptomatic stone
time frame: From Baseline through 24 months.
description: From Baseline through 24 months; will be measured by the time from Baseline to a procedure to remove a symptomatic stone by a participant.
measure: Any procedural intervention for removal of asymptomatic renal or ureteral stone
time frame: From Baseline through 24 months.
description: Will be measured by the time from Baseline to a procedure to remove an asymptomatic stone by a participant.
measure: Asymptomatic formation of new stone detected by imaging
time frame: From Baseline through 24 months.
description: Will be measured by the time from Baseline to the formation of an asymptomatic stone by a participant.
measure: Growth of existing stone by ≥ 2 mm in any dimension detected by imaging
time frame: From Baseline through 24 months.
description: Comparison of the size of any stone on first observation versus later observations or at passage. Will be measured primarily through imaging (CT scan or ultrasound).
measure: Composite outcome: symptomatic stone recurrence, asymptomatic stone formation, increase of existing stone by ≥2 mm in any dimension detected by imaging
time frame: From Baseline through 24 months.
measure: 24 hour urine total volume
time frame: From Baseline through 24 months.
description: Will measure and compare 24 hour urine volumes from screening through 24 months.
measure: Costs of study interventions and treatments for USD during the follow-up period
time frame: Compared total between Baseline and the Month 24 visit.
measure: Presence of lower urinary tract symptoms (Comprehensive Assessment of Self-reported Urinary Symptoms)
time frame: From Baseline through the Month 24 visit.
description: Will compare the results of the CASUS questionnaires completed throughout the study
arm group label: Intervention
arm group type: Experimental
description: Participants in the intervention arm will receive an individualized "fluid prescription", which will be the additional volume of fluid intake needed to maintain a study-specified urine output. This fluid will be consumed from and measured by a smart water bottle. The intervention arm also includes a behavioral program that consists of financial incentives and structured problem solving (SPS) to maintain the recommended fluid intake.
arm group label: Control
arm group type: No Intervention
description: Participants in the control arm will receive standard care instructions according to American Urological Association (AUA) guidelines to increase overall fluid consumption to achieve study-specified urine output. They will also receive a "smart" water bottle with capability to self-monitor their fluid intake.
intervention type: Behavioral
intervention name: Fluid prescription
description: The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.
arm group label: Intervention
intervention type: Behavioral
intervention name: Financial incentive
description: Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.
arm group label: Intervention
intervention type: Behavioral
intervention name: Structured Problem Solving
description: Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.
arm group label: Intervention
criteria: 
gender: All
minimum age: 12 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Scales, MD, MSHS
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://usdrn.org/
description: The Urinary Stone Disease Research Network (USDRN) website. The USDRN is the program conducting the PUSH study.
responsible party type: Sponsor
mesh term: Urinary Calculi
mesh term: Urolithiasis
mesh term: Calculi
sharing ipd: Yes
ipd description: Data and samples, for subjects who consent to sharing, will be sent to the NIDDK Data and Biological Samples Repository following database lock.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: 2 years after the last visit of the last participant randomized.
ipd access criteria: Anyone with access to the NIDDK Data and Biological Samples Repository
ipd url: https://repository.niddk.nih.gov/home/