Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
Phase: NA
Conditions: Gestational Diabetes, Diagnoses Disease, Pregnancy in Diabetic, Glucose, High Blood
Sponsor: Stanford University

 
Fasting Versus Fed: Effect of Oral Intake Prior to 
the Glucose Tolerance Test in Pregnancy 
NCT04547023 
March 15, 2021 
Dr. Yair Blumenfeld, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
Gestational diabetes (GDM) complicates approximately 400,000 pregnancies in the 
United States annually and is associated with significant adverse pregnancy outcomes, 
including increasing the lifetime risk of type 2 diabetes. The American College of 
Obstetrics and Gynecology (ACOG) recommends that all pregnant women undergo 
GDM screening between 24-28 weeks gestation utilizing a 1-hour oral glucose tolerance 
test that was designed to be administered without regard to the last meal or time of day. 
However, studies suggest that the timing of one's last meal prior to the 1-hour GDM 
screen may have a significant impact on GDM screening glucose levels. In addition, 
providers routinely alter the timing of the 1-hour GDM screen based on patients' self 
reported oral intake prior to the exam. We plan to conduct a prospective randomized trial 
comparing a 6-hour fast versus liberal oral intake within 2 hours prior to the glucose 
tolerance test in pregnancy in order to evaluate the effect of the fasting versus the fed 
state on routine GDM screening results.  
b. 
Objectives 
Gestational diabetes is associated with adverse maternal and neonatal outcomes such as 
hypertensive disorders of pregnancy, increased risk for cesarean delivery, macrosomia, 
neonatal hypoglycemia and hyperbilirubinemia, and birth trauma. Treatment of 
gestational diabetes has been shown to mitigate these outcomes. Therefore, ensuring that 
women are accurately screened for the disease will help ensure that they are diagnosed 
and treated appropriately. We aim to determine the effect of fasting versus a fed state on 
the result of the 1 hour 50-g oral GTT in pregnancy This study may have far-reaching 
implications for how patients should be counseled regarding how to prepare for this test 
in a standardized fashion.  
 

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c. 
Rationale for Research in Humans 
This study will provide information to support evidence-based guidelines to help 
providers understand how the duration from last oral intake prior to the test will affect 
test results. As this study is aimed at studying gestational diabetes, pregnant women will 
be required to be study participants. Neonatal charts of pregnant women who consent to 
be in the study will also be reviewed in order to assess the corresponding neonatal 
outcomes for this group of women.  
 
2. 
STUDY PROCEDURES 
a. 
Procedures 
Screening will be undertaken through the Lucile Packard Children's Hospital (LPCH) 
Stanford outpatient obstetrics clinic. At a new patient intake, a phone conversation is 
completed by the Obstetric RN where patients are asked if they are willing to participate 
in research studies run through our OB/Gyn department. Potential patients will be 
identified during this intake phone call. A member of the clinical care team can also ask 
the patient for permission to be contacted by the research staff. Patient will then be 
approached by the research staff for enrollment and provide informed consent for the 
study which the patient will sign either in person or through a remote/ electronic 
consenting process. After obtaining informed consent, the patient will be randomized to 
one of two groups: 1. fasting for at least 6 hours prior to the GDM screen. 2. liberal PO 
intake within 2 hours of the GDM screen. Patients will then undergo the 1 hour glucose 
tolerance screening test for gestational diabetes at the same gestational age they would 
normally take the test (after 24 weeks gestation) as per standard of care. Water intake is 
allowed in the fasting group. During the time of the glucose screening, patients will be 
required to complete a short online/phone survey detailing when their last oral intake was 
and what it consisted of. Women who screen positive with glucose results greater than or 
equal to 140 mg/dL will then be required to undergo a fasting 3 hour oral glucose 
tolerance test which is according to standard of care. ACOG currently endorses a positive 
screening result for the 1 hour glucose tolerance test that ranges from 130-140 mg/dL. 
LPCH Obstetrics outpatient clinic typically uses 140 mg/dL as the screen positive cutoff. 
A 140 mg/dL cutoff will be used for women enrolled in the study. A medical chart 
review will be performed for all patients and their neonates after delivery. 
b. 
Procedure Risks 
The blood draws and glucose testings that are being performed are part of the standard of 
care for any pregnant woman in the screening and diagnosis of gestational diabetes. 
Currently, the recommendation is that the 1 hour screening test be administered without 
regard to the time of day or last oral intake. This study will randomize women to a fasting 
vs fed group prior to the GDM screen. A 6 hour fast has not been shown to have any 
deleterious effects in pregnancy. 
c. 
Alternative Procedures or Courses of Treatment 
This study is following standard of care guidelines for the screening for gestational 
diabetes. Patients may elect not to participate in the study and therefore decide for 

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themselves when their last oral intake will be prior to the 1 hour oral glucose tolerance 
test.  
d. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
All patients will be treated by their clinical providers according to their usual treatment 
protocols and standard of care. Clinical providers will determine the type of treatment the 
patient will receive during their pregnancy and postpartum. 
e. 
Study Endpoint(s) 
The protocol director and investigators who serve as the data and safety monitors will be 
responsible for addressing whether there are any safety concerns related to the study or if 
there is any need to terminate the study before target enrollments are completed. 
Unanticipated problems or adverse events will be reported to the IRB. The study will end 
after the target enrollment has been completed. 
3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Gestational diabetes (GDM) is characterized by a state of insulin resistance in the second 
and third trimester, with the prevalence being estimated at up to 9% in the United States 
[1,2]. Women with gestational diabetes have a higher risk of large for gestational age 
(LGA) infants, neonatal hypoglycemia, hyperbilirubinemia, cesarean delivery, shoulder 
dystocia, preeclampsia, and birth trauma [2–5]. The Hyperglycemia and Adverse 
Pregnancy Outcomes (HAPO) trial further demonstrated a continuous association 
between hyperglycemia and the risk of adverse maternal and neonatal outcomes [3], and 
treatment of gestational diabetes has been shown to significantly decrease the risk of 
maternal and neonatal morbidity[6]. Screening for gestational diabetes is routinely 
performed between 24- 28 weeks gestation in all pregnancies, with early screening being 
utilized for those with risk factors that would lead to a predisposition for GDM or 
pregestational diabetes [2]. In the United States, the two step approach is commonly 
employed which utilizes a 1-hr 50-g oral glucose tolerance test for screening followed by 
a 100-g 3-hr glucose tolerance test for those who screen positive on the screening test to 
confirm the diagnosis of GDM. Cutoff values for a positive screen range from 130 mg/dL 
– 140 mg/dL and vary by institution [2,7,8]. The 1-hour oral glucose tolerance test is 
traditionally obtained without regard to time of day or time of last meal [7,9–12]. There 
are no societal guidelines regarding appropriate oral intake prior to the test, and there 
appears to be discordant advice given to patients regarding whether or not they should 
fast prior to the test. Moreover, contrary to patients' and providers' intuition, small cohort 
studies suggest that fasting prior to the GDM screen may actually lead to an increase in 
the 1 hour result, and it has previously been suggested that different cutoff values may be 
considered when the test is administered in the fasting versus the fed state [7,9,13–16]. 
Coustan et al performed a prospective crossover study in 1986 that looked at 20 known 
gestational diabetics and 50 presumed normal patients. Patients were administered the 1 
hour glucose tolerance test 1 hour after receiving a standardized meal and then a week 
later fasted and took the test. They found that fasting only made a significant difference 

March 15, 2021 
 
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in the glucose levels for the known gestational diabetics but not for the presumed normal 
controls [13]. A more recent study by Hancerliogullari et al from Turkey in 2018 
surveyed women prior to their 1 hour GDM screen to determine the effect of fasting on 
the GDM screen glucose levels [16]. They found a significant difference in GDM screen 
glucose values following a 6.5 hour fast, with fasting leading to a higher glucose level 
[16]. However, much of the data regarding the 1 hour glucose tolerance test is based upon 
cohorts from the 1960-1980s with few studies examining this screening test in a modern 
cohort. It is well recognized that pregnant women today are generally older, more 
diverse, and have higher BMIs than women 40 years ago; therefore determining optimal 
GDM screen strategies in a modern cohort is warranted. Our goal is to use evidence 
based methodology to determine the effect of a fasting vs fed state prior to the routine 
GDM screen in pregnancy.  
 
1. Casagrande SS, Linder B, Cowie CC. Prevalence of gestational diabetes and 
subsequent Type 2 diabetes among U.S. women. Diabetes Res Clin Pract. 2018;141:200-
208. 
2. Gestational Diabetes Mellitus. 2018;131(2):16.  
3. HAPO Study Cooperative Research Group. The Hyperglycemia and Adverse 
Pregnancy Outcome (HAPO) Study. Int J Gynecol Obstet. 2002;78(1):69-77.  
4. McIntyre HD, Metzger BE, Coustan DR, et al. Counterpoint: Establishing Consensus 
in the Diagnosis of GDM Following the HAPO Study. Curr Diab Rep. 2014;14(6):497.  
5. O'Sullivan JB, Charles D, Mahan CM, Dandrow RV. Gestational diabetes and 
perinatal mortality rate. Am J Obstet Gynecol. 1973;116(7):901-904.  
6. Landon MB. The NICHD maternal and fetal medicine unit (MFMU) network 
gestational diabetes mellitus trial: Can we use the results as the basis for changing current 
screening approaches? J Matern Fetal Neonatal Med. 2010;23(3):210-213.  
7. O'Sullivan JB, Mahan CM, Charles D, Dandrow RV. Screening criteria for high-risk 
gestational diabetic patients. Am J Obstet Gynecol. 1973;116(7):895-900.  
8. Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J 
Obstet Gynecol. 1982;144(7):768-773.  
9. O'Sullivan JB, Grant ME, Francis JO. Glucose Tolerance Test Standardization 
Simplified by Urinary Ketone Testing. Public Health Rep 1896-1970. 1965;80(3):220. 
10. Levitt C. Diagnosis and Control: A Review. 1988;34:6.  
11. Teplick FB, Lindenbaum CR, Cohen AW. Cost-effective approach to office screening 
for gestational diabetes. J Perinatol Off J Calif Perinat Assoc. 1990;10(3):301-303.  
12. Summary and Recommendations of the Second International WorkshopConference 
on Gestational Diabetes Mellitus. Diabetes. 1985;34(Supplement_2):123-126.  
13. Coustan DR, Widness JA, Carpenter MW, Rotondo L, Pratt DC, Oh W. Should the 
fifty-gram, one-hour plasma glucose screening test for gestational diabetes be 
administered in the fasting or fed state? Am J Obstet Gynecol. 1986;154(5):1031-1035. 
14. Wang P, Lu M-C, Yu C-W, Yan Y-H. Influence of the Time of Day and Fasting 
Duration on Glucose Level following a 1-Hour, 50-Gram Glucose Challenge Test in 
Pregnant Women. Siribaddana S, ed. PLoS ONE. 2014;9(11):e112526.  
15. Wang P, Lu M-C, Yu C-W, Wang L-C, Yan Y-H. Influence of Food Intake on the 
Predictive Value of the Gestational Diabetes Mellitus Screening Test: Obstet Gynecol. 
2013;121(4):750-758.  

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16. Hancerliogullari N, Celik H, Karakaya B, et al. Effect of Prolonged Fasting Duration 
on 50 Gram Oral Glucose Challenge Test in the Diagnosis of Gestational Diabetes 
Mellitus. Horm Metab Res. 2018;50(09):671-674.  
 
 
 
4. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
We estimate a total sample size of 200 women (100 women in each study arm) is 
required for this study based on a power calculation at power = 0.8, alpha = 0.05, and a 
20% difference in screen positive rate between the fed versus fasting group. Patients will 
be enrolled at Lucile Packard Children's Hospital (LPCH) Stanford. No other external 
sites will be involved in the study. All enrolled participants will be pregnant patients as 
this study aims to investigate the effect of oral intake prior to the 1 hour oral glucose 
challenge test for gestational diabetes. 
b. 
Age, Gender, and Ethnic Background 
The patient population is pregnant women of childbearing age (more than or equal to 18 
years old) including their infants from the current pregnancy. Ethnic background will 
reflect the local and regional population. 
c. 
Vulnerable Populations 
All participants in this trial will be pregnant women as we are studying gestational 
diabetes which is a unique disease state that occurs in pregnancy. However, we are 
following standard of care in terms of the timing of the blood draw in pregnancy and also 
in the quantity of the blood draw. Pregnant women identified as eligible for the study will 
be counseled by members of the team regarding benefits and risks with participation. A 
written informed consent form will be obtained from all participants. If at any time 
participants wish to withdraw, they will be allowed to do so. All pregnant women 
obtaining prenatal care at the outpatient obstetrics clinics of LPCH may be eligible for the 
study. Some of these may be homeless women, economically and educationally 
disadvantaged women, employees, and/or students, though specific cohorts will not be 
targeted. Neonates of women enrolled in the study will not have any blood draws or any 
other interventions performed as part of the study but neonates will have information 
abstracted from their charts to correlate neonatal outcomes with maternal findings. There 
will be no changes to neonatal care from this study. 
d. 
Rationale for Exclusion of Certain Populations 
This study will not be offered to pregnant minors (age < 18 years old) because we 
anticipate to reach our enrollment goal in the pregnant population that is greater than or 
equal to 18 years old. 
e. 
Stanford Populations 

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Laboratory personnel, employees, and students may be recruited if they meet inclusion 
criteria, using the same informed consent and treatment protocol as other participants. It 
is not possible to estimate the number of such participants, but they will likely represent a 
small minority of the total subjects recruited. 
 
f. 
Healthy Volunteers 
Only pregnant women will be included. 
g. 
Recruitment Details 
Women potentially eligible for the study will be identified by preliminary screening of 
LPCH outpatient obstetric clinic medical records. A member of the care team will notify 
the potential participant about their eligibility for the research study and will obtain the 
patient's permission before the research team can approach. The medical record review 
will also determine the inclusion/exclusion criteria for the study. If eligible, the study will 
be discussed and reviewed with the patient. We will also address questions or concerns. If 
the patient is interested, she will be consented and enrolled in the study. A description of 
the study will also be listed on the Maternal Fetal Medicine Research (MFM) Studies 
flyer. This flyer is included in the New OB packet, which is given to every pregnant 
women during their initial OB visit at the LPCH OB Clinic. If the patient is interested, 
she can reach out to our team, and we will discuss the study and any questions or 
concerns. If still interested, she will be consented and enrolled in the study. Recruitment 
materials will be submitted to IRB prior to use. The study will be registered on 
ClinicalTrials.gov and the Stanford school of medicine website 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
1) Pregnant patients 18 years and older  
2) Planned delivery to occur at LCPH Labor and Delivery unit  
3) Pregnancy being followed by LPCH outpatient obstetrics clinic  
4) Singleton pregnancy 
ii. 
Exclusion Criteria 
1) Pregestational diabetes  
2) Gestational diabetes diagnosed in the 1st trimester  
3) Diabetes medication use prior to pregnancy  
4) Inability to give informed consent  
5) Chronic steroid use in pregnancy  
6) Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test 
7) Prior history of bariatric surgery 
i. 
Screening Procedures 
Women receiving prenatal care at the LPCH Obstetric clinic will be screened if eligible 
for the study. Potential participants will be identified by review of electronic medical 
records which will include the collection of personal health information. If eligible, the 

March 15, 2021 
 
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participant will be approached to review the study and have questions answered. If the 
patient provides consent, she will be enrolled in the study. 
 
 
 
j. 
Participation in Multiple Protocols 
Patients will be asked if they are participating in any other research protocols during the 
consenting process. If the patient is already participating in other research studies, she 
will not be enrolled if the study procedures involved will conflict with what is required in 
the protocol. 
k. 
Payments to Participants 
Patients participating in the study will receive a token gift of a $15 gift card to 
demonstrate appreciation for their participation in the study. This level of compensation 
is within the category of token level of appreciation and will not constitute undue 
pressure on participants to participate in this study. 
l. 
Costs to Participants 
No additional costs will be charged to the patient. 
m. 
Planned Duration of the Study 
The estimated length of time for the study is approximately 18 months with 15 months of 
enrollment and 3 months of data analysis and summarization of findings.  
 
10/2020-12/2021: Patient recruitment and enrollment. We anticipate that all 200 patients 
will be enrolled during this timeline. All patients enrolled will ensure delivery is by the 
end of 02/2022.  
02/2022-04/2022: Data analysis  
04/2022-06/2022: Manuscript development and submission  
 
The total time per participant includes: (i) enrollment activities (30 minutes) via remote 
process or at LPCH obstetrics clinic, (ii) active participation to include a universal 1 hour 
oral glucose challenge test at 24 weeks of gestation or greater to screen for gestational 
diabetes which is standard in all pregnancies. Non active participation will include chart 
review of the patient's medical records and the associated neonatal medical records (iii) 
Analysis of data - 3 months. 
5. 
RISKS 
a. 
Potential Risks 
i. 
Commercially available drugs, biologics, reagents or chemicals 
Every pregnant woman (irrespective of participation in the study) undergoes a routine 
gestational diabetes screen using a 50 g glucose drink. Side effect of the drink includes 
nausea, vomiting, abdominal bloating, and/or headache. Women participating in the study 

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will have a GDM screen using a 50 g glucose drink that is identical to those not 
participating in the study. 
 
 
 
ii. 
Procedures 
Every pregnant woman (irrespective of participation in the study) has a blood draw that is 
a part of the GDM screen. Women participating in the study will also have a blood draw 
as a part of the GDM screen. The risks of a blood draw includes discomfort at the site of 
puncture, possible bruising, redness, and swelling around the site, bleeding at the site, 
feeling lightheadedness when the blood is drawn, and rarely, an infection at the site of the 
blood draw. 
iii. 
Overall evaluation of risk 
 
The protocol is no more than minimal risk (i.e., "not greater than those ordinarily 
 
encountered in daily life") AND only involve human subjects as described below: 
 
• 
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture 
as follows:  
 
 
a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these  
 
 
subjects, the amounts drawn may not exceed 550 ml in an 8 week period and  
 
 
collection may not occur more frequently than 2 times per week; or  
 
 
b) from other adults and children, considering the age, weight, and health of the  
 
 
subjects, the collection procedure, the amount of blood to be collected, and the  
 
 
frequency with  which it will be collected. For these subjects, the amount drawn  
 
 
may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and  
 
 
collection may not occur more frequently than 2 times per week. 
• 
Research involving materials (data, documents, records, or specimens) that have 
been collected, or will be collected solely for nonresearch purposes (such as 
medical treatment or diagnosis).  
• 
Research on individual or group characteristics or behavior (including, but not 
limited to, research on perception, cognition, motivation, identity, language, 
communication, cultural beliefs or practices, and social behavior) or research 
employing survey, interview, oral history, focus group, program evaluation, 
human factors evaluation, or quality assurance methodologies.  
b. 
International Research Risk Procedures 
Not Applicable. 
c. 
Procedures to Minimize Risk 
Standard safety procedures will be followed to minimize risk associated with blood draw 
including the use of gloves and cleansing of area where venipuncture is to be performed 
with alcohol. In addition, the 1 hour glucose tolerance test will be administered during the 
standard time of pregnancy at 24 weeks of gestation or greater. With regards to protecting 
patient confidentiality, we will assign each participant a study code that will be based on 

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the order of their enrollment and will have no reference to any personal identifying 
information. We will keep an electronic list that connects patient names with study codes 
during the data collection period. This list will be kept on a password-protected 
document, on a password-protected/ encrypted computer in a locked office in the 
administrative offices of the Department of Obstetrics and Gynecology, or entered into a 
secure server such as RedCap, Encore and Box. Access to the databases will only be 
granted to the research team included under the IRB protocol. 
d. 
Study Conclusion 
The study will terminate once enrollment goal is achieved. If the patient experiences a 
rare adverse reaction to a blood draw or from the glucose drink, the obstetrician will be 
notified and will treat the event per usual standard practice (e.g. monitor vital signs, treat 
with ice packs, antibiotics, etc if needed). 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
For women who are participating in the study, neonatal charts will be reviewed to 
correlate maternal findings with neonatal outcomes. This study poses no risk to 
neonates as they will continue to receive routine care as provided by their care team 
and will not undergo any blood draws or interventions due to the study. Only 
neonates (0-28 days of life) of women who consent to participate in this study will be 
included and thus neonates will not be able to give assent. Consent for chart review 
of the neonates will be obtained from the mother when gives consent for HIPPA 
authorization. 
ii. 
Person(s) responsible for Data and Safety Monitoring 
N/A 
iii. 
Frequency of DSMB meetings 
N/A 
iv. 
Specific triggers or stopping rules 
N/A 
v. 
DSMB Reporting 
N/A 
vi. 
Will the Protocol Director be the only monitoring entity? (Y/N) 
N/A 
vii. 
Will a board, committee, or safety monitor be responsible for study monitoring? 
(Y/N) 
No 
f. 
Risks to Special Populations 

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Children’s Findings OHRP: 46.404 Research not involving greater than minimal risk.  
The research must present no greater than minimal risk to children and adequate 
provisions must be made for soliciting the assent of the children and the permission 
of their parents or guardians. For women who are participating in the study, neonatal 
charts will be reviewed to correlate maternal findings with neonatal outcomes. This 
study poses no risk to neonates as they will continue to receive routine care as 
provided by their care team and will not undergo any blood draws or interventions 
due to the study. Only neonates (0-28 days of life) of women who consent to 
participate in this study will be included and thus neonates will not be able to give 
assent. Consent for chart review of the neonates will be obtained from the mother 
when gives consent for HIPPA authorization. 
  
Pregnant Women or Fetuses: All of the following conditions are met: 
 
Met  
a) Where scientifically appropriate, preclinical studies, including studies on 
 
pregnant animals, and clinical studies, including studies on nonpregnant women, 
 
have been conducted and provide data assessing potential risks to pregnant 
 
women and fetuses;  
Met  
b) The risk to the fetus is caused solely by interventions or procedures that hold 
 
out the prospect of direct benefit for the woman or the fetus; or, if there is no 
 
such prospect of benefit, the risk to the fetus is not greater than minimal and the 
 
purpose of the research is the development of important biomedical knowledge 
 
which cannot be obtained by any other means;  
Met  
c) Any risk is the least possible for achieving the objectives of the research;  
Met  
d) If the research holds out the prospect of direct benefit to the pregnant woman, 
 
the prospect of a direct benefit both to the pregnant woman and the fetus, or no 
 
prospect of benefit for the woman nor the fetus when risk to the fetus is not 
 
greater than minimal and the purpose of the research is the development of 
 
important biomedical knowledge that cannot be obtained by any other means , 
 
her consent is obtained in accord with the informed consent provisions of subpart 
 
A of this part;  
N/A  
e) If the research holds out the prospect of direct benefit solely to the fetus then 
 
the consent of the pregnant woman and the father is obtained in accord with the 
 
informed consent provisions of subpart A of this part, except that the father's 
 
consent need not be obtained if he is unable to consent because of` unavailability 
 
, incompetence, or temporary incapacity or the pregnancy resulted from rape or 
 
incest.  
Met  
f) Each individual providing consent under paragraph (d) or (e) of this section is 
 
fully informed regarding the reasonably foreseeable impact of the research on the 
 
fetus or neonate;  
N/A  
g) For children as defined in Sec. 46.402(a) who are pregnant, assent and 
 
permission are obtained in accord with the provisions of subpart D of this part; 
Met 
h) No inducements, monetary or otherwise, will be offered to terminate a 
 
pregnancy;  
Met  
i) Individual engaged in the research will have no part in any decisions as to the 
 
timing, method, or procedures used to terminate a pregnancy;  

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Met  
j) Individual engaged in the research will have no part in determining the 
 
viability of a neonate. 
6. 
BENEFITS 
The participants will not benefit directly by participating in this study, as they would receive 
equally appropriate treatment should they choose not to participate. The knowledge gained in this 
study will be important in establishing the effect of oral intake prior to the routine GDM 
screening test. 
7. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.