Gestational DiabetesNCT04547023
Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
A study testing Fasting before gestational diabetes screen and Per oral intake of food and drink in people with Gestational Diabetes and Diagnoses Disease, run by Stanford University at 1 site in United States.
Trial summary
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Diagnoses Disease, Pregnancy in Diabetic
- What is being tested?
- Fasting before gestational diabetes screen and Per oral intake of food and drink
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant patients 18 years and older
- Singleton gestation
- Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
- Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit
Who cannot join
- Pregestational diabetes
- Gestational diabetes diagnosed in the 1st trimester
- Less than 18 years of age
- Planned delivery outside LPCH
- Diabetes medication use prior to pregnancy
- Inability to give informed consent
Show all 10Show fewer
- Chronic steroid use in pregnancy
- Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test
- Prior history of bariatric surgery
- Multifetal gestation
Trial locations and contacts
1 site in 1 country.
About this study
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators 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 gestational diabetes screening results.
Read the detailed description
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 Obstetricians and Gynecologists (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. The investigators 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.
- Being tested
- Fasting before gestational diabetes screen, Per oral intake of food and drink
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting before gestational diabetes screenBehavioural
Fasting for at least 6 hours before 1-hour gestational diabetes screen.
Per oral intake of food and drinkBehavioural
Per oral intake of food and drink within 2 hours of gestational diabetes screen
| Study group | Role | What they receive |
|---|---|---|
| Fasting before gestational diabetes screen | Experimental | Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen. Receives: Behavioral: Fasting before gestational diabetes screen |
| Fed before gestational diabetes screen | Active comparator | Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. Receives: Behavioral: Per oral intake of food and drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT)
Number of positive GDM screen (>= 140 mg/dL) on the 1 hour 50-g oral glucose tolerance test conducted between 24-28 weeks gestation This outcome was assessed in pregnant participants.
Measured: Day of GDM screen (occurring between 24-28 weeks gestation)
Secondary outcomes (27)
Mean Gestational Age at OGTT Screen
Measured: Day of GDM screen (occurring between 24-28 weeks gestation)
Mean Glucose Level at the OGTT Screen
Measured: Day of GDM screen (occurring between 24-28 weeks gestation)
Number of Participants With Positive GDM Diagnosis Based on the OGTT
This outcome was assessed in pregnant participants.
Measured: Day of GDM screen (occurring between 24-28 weeks gestation)
Average Time of Last Oral Intake Prior to the OGTT Screen
Average number of hours since the participant's last oral intake prior to OGTT screen
Measured: Day of GDM screen (occurring between 24-28 weeks gestation)
Number of Participants With Positive GDM Diagnosis
GDM diagnosis based on 1-hour OGTT ≥ 180 mg/dL or 2 elevated values on the 3-hour OGTT using Carpenter and Coustan criteria. This outcome was assessed in pregnant participants
Carpenter and Coustan Criteria is as follows (if 2 or more values are elevated, this is gestational diabetes):
- Fasting glucose < 95;
- One hour glucose < 180;
- Two hour glucose < 155;
- Three hour glucose < 140
Measured: Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)
Mean Gestational Age at Delivery
Measured: At time of delivery (Up to 42 weeks' gestation)
Number of Participants Who Delivered Vaginally
This outcome was assessed in pregnant participants.
Measured: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Via Operative Vaginal Birth
This outcome was assessed in pregnant participants.
Measured: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Vaginally After a Prior Cesarean Section
This outcome was assessed in pregnant participants.
Measured: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Via a Primary Cesarean Section
Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.
Measured: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Via a Repeat Cesarean Section
This outcome was assessed in pregnant participants.
Measured: At time of delivery (up to 42 weeks' gestation)
Number of Participants Complicated by Shoulder Dystocia at Delivery
Shoulder dystocia is a birth injury (also called birth trauma) that happens when one or both of a baby's shoulders get stuck inside the mother's pelvis during labor and birth. This outcome was assessed in pregnant participants.
Measured: At time of delivery (up to 42 weeks' gestation)
Number of Participants Complicated by Third or Fourth Degree Perineal Laceration
A third degree tear is a tear or laceration through the perineal muscles and the anal sphincter. A fourth degree tear goes through the anal sphincter all the way to the anal canal or rectum. This outcome was assessed in pregnant participants.
Measured: At time of delivery (up to 42 weeks' gestation)
Number of Participants With Post-partum Hemorrhage
This outcome was assessed in pregnant participants after delivery.
Measured: Up to 6 weeks after delivery
Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy
This outcome was assessed in pregnant participants.
Measured: From time of GDM screen up to 6 weeks after delivery
Length of Postnatal Stay From Delivery to Discharge
Average number of days admitted in the hospital after delivery up to discharge
Measured: Up to 1 week after delivery
Number of Participants Who Had a Postpartum Readmission
This outcome was assessed in pregnant participants post-delivery.
Measured: From initial hospital discharge up to 6 weeks post-partum
Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum
This outcome was assessed in pregnant participants after delivery.
Measured: From time of delivery up to 6 weeks post-partum
Mean Neonatal Birthweight
Measured: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates With Birth Weight More Than 4000 Grams
Measured: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates Considered Large for Gestational Age (LGA)
LGA refers to neonatal birth weight larger than the 90th percentile for gestational age.
Measured: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates Considered Small for Gestational Age (SGA)
SGA are infants whose weight is < the 10th percentile for gestational age.
Measured: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
Measured: Up to 28 days after delivery
Number of Neonates With Hyperbilirubinemia
Measured: Up to 28 days after delivery
Number of Neonates With Hypoglycemia
Measured: Up to 28 days after delivery
Number of Neonates Diagnosed With Respiratory Distress Syndrome
Measured: Up to 28 days after delivery
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge
Measured: Up to 28 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start2 Nov 2020
- Primary completion21 Jun 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Blumenfeld, Stanford University
- Investigators
- Yair Blumenfeld, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547023
- Sponsor's protocol ID
- 57772
- Other IDs
- P30DK116074
- Status last verified
- Oct 2022
- First submitted
- 4 Sep 2020
- Last updated
- 21 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sperling MM, Leonard SA, Miller SE, Hurtado J, El-Sayed YY, Herrero T, Faig J, Carter S, Blumenfeld YJ. Fasting Compared With Fed and Oral Intake Before the 1-Hour Oral Glucose Tolerance Test: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jan 1;141(1):126-133. doi: 10.1097/AOG.0000000000005013. Epub 2022 Nov 30.
PubMed 36701613
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy
- ClinicalTrials.gov ID
- NCT04547023
- Acronym / sponsor ID
- 57772
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 21 Jun 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 14 Sep 2020 (actual)
- Results
- Posted 21 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies suggest that the timing interval between oral intake and the 1-hour gestational diabetes screen may have a significant impact on gestational diabetes screening glucose levels. The investigators 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 gestational diabetes screening results.
Detailed description
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 Obstetricians and Gynecologists (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. The investigators 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting before gestational diabetes screen | Experimental | Behavioral: Fasting before gestational diabetes screenFasting for at least 6 hours prior to the 1-hour gestational diabetes screen. |
| Fed before gestational diabetes screen | Active comparator | Behavioral: Per oral intake of food and drinkLiberal per oral intake within 2 hours of the 1-hour gestational diabetes screen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant patients 18 years and older
- Singleton gestation
- Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
- Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit
Key exclusion criteria (10 listed)
- Pregestational diabetes
- Gestational diabetes diagnosed in the 1st trimester
- Less than 18 years of age
- Planned delivery outside LPCH
- Diabetes medication use prior to pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting before gestational diabetes screenFasting for at least 6 hours before 1-hour gestational diabetes screen. | Behavioural | Fasting before gestational diabetes screen |
| Per oral intake of food and drinkPer oral intake of food and drink within 2 hours of gestational diabetes screen | Behavioural | Fed before gestational diabetes screen |
Primary outcome
Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT)
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Number of positive GDM screen (>= 140 mg/dL) on the 1 hour 50-g oral glucose tolerance test conducted between 24-28 weeks gestation This outcome was assessed in pregnant participants.
27 secondary outcomes
Mean Gestational Age at OGTT Screen
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Mean Glucose Level at the OGTT Screen
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Number of Participants With Positive GDM Diagnosis Based on the OGTT
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Average Time of Last Oral Intake Prior to the OGTT Screen
Time frame: Day of GDM screen (occurring between 24-28 weeks gestation)
Number of Participants With Positive GDM Diagnosis
Time frame: Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)
Mean Gestational Age at Delivery
Time frame: At time of delivery (Up to 42 weeks' gestation)
Number of Participants Who Delivered Vaginally
Time frame: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Via Operative Vaginal Birth
Time frame: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Vaginally After a Prior Cesarean Section
Time frame: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Via a Primary Cesarean Section
Time frame: At time of delivery (up to 42 weeks' gestation)
Number of Participants Who Delivered Via a Repeat Cesarean Section
Time frame: At time of delivery (up to 42 weeks' gestation)
Number of Participants Complicated by Shoulder Dystocia at Delivery
Time frame: At time of delivery (up to 42 weeks' gestation)
Number of Participants Complicated by Third or Fourth Degree Perineal Laceration
Time frame: At time of delivery (up to 42 weeks' gestation)
Number of Participants With Post-partum Hemorrhage
Time frame: Up to 6 weeks after delivery
Number of Participants Diagnosed With a Hypertensive Disorder of Pregnancy
Time frame: From time of GDM screen up to 6 weeks after delivery
Length of Postnatal Stay From Delivery to Discharge
Time frame: Up to 1 week after delivery
Number of Participants Who Had a Postpartum Readmission
Time frame: From initial hospital discharge up to 6 weeks post-partum
Number of Participants With Type 2 Diabetes Mellitus Diagnosis Post-partum
Time frame: From time of delivery up to 6 weeks post-partum
Mean Neonatal Birthweight
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates With Birth Weight More Than 4000 Grams
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates Considered Large for Gestational Age (LGA)
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates Considered Small for Gestational Age (SGA)
Time frame: Day of delivery (Within approximately 2 hours after delivery)
Number of Neonates Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: Up to 28 days after delivery
Number of Neonates With Hyperbilirubinemia
Time frame: Up to 28 days after delivery
Number of Neonates With Hypoglycemia
Time frame: Up to 28 days after delivery
Number of Neonates Diagnosed With Respiratory Distress Syndrome
Time frame: Up to 28 days after delivery
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge
Time frame: Up to 28 days after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36701613Sperling MM, Leonard SA, Miller SE, Hurtado J, El-Sayed YY, Herrero T, Faig J, Carter S, Blumenfeld YJ. Fasting Compared With Fed and Oral Intake Before the 1-Hour Oral Glucose Tolerance Test: A Randomized Controlled Trial. Obstet Gynecol. 2023 Jan 1;141(1):126-133. doi: 10.1097/AOG.0000000000005013. Epub 2022 Nov 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yair Blumenfeld, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting before gestational diabetes screen and Per oral intake of food and drink in people with Gestational Diabetes and Diagnoses Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With a Positive Gestational Diabetes Mellitus (GDM) Screen (>= 140 mg/dL) on the 1 Hour 50-g Oral Glucose Tolerance Test (OGTT) (time frame: Day of GDM screen (occurring between 24-28 weeks gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04547023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.