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

NCT04547023 | Completed Results

• 2 other identifiers: 57772P30DK116074
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gestational Diabetes; Diagnoses Disease; Pregnancy in Diabetic; Glucose, High Blood

Outcome Measures

Primary Outcomes (1)

• 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.

  Day of GDM screen (occurring between 24-28 weeks gestation)

Secondary Outcomes (27)

• Mean Gestational Age at OGTT Screen

  Day of GDM screen (occurring between 24-28 weeks gestation)

• Mean Glucose Level at the OGTT Screen

  Day of GDM screen (occurring between 24-28 weeks gestation)

• Number of Participants With Positive GDM Diagnosis Based on the OGTT

  Day of GDM screen (occurring between 24-28 weeks gestation)

• Average Time of Last Oral Intake Prior to the OGTT Screen

  Day of GDM screen (occurring between 24-28 weeks gestation)

• Number of Participants With Positive GDM Diagnosis

  Day of OGTT (occurring at 24-28 weeks gestation up to 42 weeks gestation)

Study Arms (2)

Fasting before gestational diabetes screen

EXPERIMENTAL

Fasting for at least 6 hours prior to the 1-hour gestational diabetes screen.

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.

Behavioral: Per oral intake of food and drink

Interventions

Fasting before gestational diabetes screen BEHAVIORAL

Fasting for at least 6 hours before 1-hour gestational diabetes screen.

Fasting before gestational diabetes screen

Per oral intake of food and drink BEHAVIORAL

Per oral intake of food and drink within 2 hours of gestational diabetes screen

Fed before gestational diabetes screen

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 36701613 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy in Diabetics

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Yair Blumenfeld, MD
• Organization: Stanford University

yairb@stanford.edu

650-498-4069

Study Officials

• Yair Blumenfeld, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 14, 2020
• Study Start: November 2, 2020
• Primary Completion: June 21, 2021
• Study Completion: November 1, 2021
• Last Updated: November 21, 2022
• Results First Posted: November 21, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)