Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy

October 26, 2022 updated by: Yair Blumenfeld, Stanford University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Pregnant patients 18 years and older
  2. Singleton gestation
  3. Pregnancy managed at Lucile Packard Children's Hospital (LPCH) Stanford outpatient obstetrics clinic
  4. Planned delivery at Lucile Packard Children's Hospital (LPCH) Stanford Labor and Delivery unit

Exclusion Criteria:

  1. Pregestational diabetes
  2. Gestational diabetes diagnosed in the 1st trimester
  3. Less than 18 years of age
  4. Planned delivery outside LPCH
  5. Diabetes medication use prior to pregnancy
  6. Inability to give informed consent
  7. Chronic steroid use in pregnancy
  8. Less than 24 weeks of gestation at the time of the 1 hour oral glucose tolerance test
  9. Prior history of bariatric surgery
  10. Multifetal gestation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Fasting before gestational diabetes screen
Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.
Behavioral: Fasting before gestational diabetes screen
Fasting for at least 6 hours before 1-hour gestational diabetes screen.
ACTIVE_COMPARATOR: Fed before gestational diabetes screen
Liberal per oral intake within 2 hours of the 1-hour gestational diabetes screen.
Behavioral: Per oral intake of food and drink
Per oral intake of food and drink within 2 hours of gestational diabetes screen

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day of GDM screen (occurring between 24-28 weeks gestation)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Gestational Age at OGTT Screen
Time Frame: Day of GDM screen (occurring between 24-28 weeks gestation)
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)
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)
This outcome was assessed in pregnant participants.
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)
Average number of hours since the participant's last oral intake prior to OGTT screen
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)

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
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)
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)
This outcome was assessed in pregnant participants.
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)
This outcome was assessed in pregnant participants.
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)
This outcome was assessed in pregnant participants.
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)
Primary = first Cesarean section for participant. This outcome was assessed in pregnant participants.
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)
This outcome was assessed in pregnant participants.
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)
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.
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)
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.
At time of delivery (up to 42 weeks' gestation)
Number of Participants With Post-partum Hemorrhage
Time Frame: Up to 6 weeks after delivery
This outcome was assessed in pregnant participants after delivery.
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
This outcome was assessed in pregnant participants.
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
Average number of days admitted in the hospital after delivery up to discharge
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
This outcome was assessed in pregnant participants post-delivery.
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
This outcome was assessed in pregnant participants after delivery.
From time of delivery up to 6 weeks post-partum
Mean Neonatal Birthweight
Time Frame: Day of delivery (Within approximately 2 hours after delivery)
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)
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)
LGA refers to neonatal birth weight larger than the 90th percentile for gestational age.
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)
SGA are infants whose weight is < the 10th percentile for gestational age.
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
Up to 28 days after delivery
Number of Neonates With Hyperbilirubinemia
Time Frame: Up to 28 days after delivery
Up to 28 days after delivery
Number of Neonates With Hypoglycemia
Time Frame: Up to 28 days after delivery
Up to 28 days after delivery
Number of Neonates Diagnosed With Respiratory Distress Syndrome
Time Frame: Up to 28 days after delivery
Up to 28 days after delivery
Number of Neonates Exclusively Breastfeeding at Time of Hospital Discharge
Time Frame: Up to 28 days after delivery
Up to 28 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yair Blumenfeld, MD, Associate professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 21, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 57772
  • P30DK116074 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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