Glucose Control in Type 2 Diabetes in Pregnancy

November 18, 2025 updated by: Marwan Ma'ayeh, Eastern Virginia Medical School

Postprandial Walks for Glucose Control in Type 2 Diabetes in Pregnancy

The goal of this clinical trial is to evaluate the effect of physical activity on glucose control in pregnant patients with pregestational Type 2 diabetes. The main question it seeks to answer is "will physical activity following a meal improve blood sugar control in pregnant women with Type 2 diabetes?" Researchers will compare the glucose control of two groups: one that walks for 20 minutes after each meal, and one that does not.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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 (Estimated)

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.
40

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School, Macon and Joan Brock Virginia Health Sciences at Old Dominion University
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Singleton gestation
  • Known diagnosis of Type 2 diabetes OR meets new diagnosis of Type 2 diabetes in the first trimester (up to 13 weeks and 6 days)
  • Age ≥18 and <50 years
  • Gestational age <32 weeks 0 days gestation

Exclusion Criteria:

  • Non-English as the primary language
  • Inability to participate in 20 minutes of walking at a time
  • Known or suspected fetal anomaly or aneuploidy
  • Prisoners
  • Management of diabetes outside of study location

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: Post-prandial walk
Participants in this arm of the study will be instructed to walk for 20 minutes after each meal (breakfast, lunch, and dinner). They will also be given a continuous glucose monitor and a FitBit, to wear throughout their participation in the study.
Behavioral: Exercise
This intervention consists of instructions to walk for 20 minutes after each meal.
No Intervention: Standard of Care
Participants in this arm will be given the regular counseling on the importance of exercise during pregnancy, but not instructed to walk after each meal. They will receive a continuous glucose monitor and FitBit to wear throughout their participation in the study.

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
Blood Glucose Time in Range
Time Frame: Between 34 and 36 weeks gestation.
Our primary outcome is the time in range (via CGM data) during the management of Type 2 diabetes in pregnancy between 34 and 36 weeks gestation.
Between 34 and 36 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
Duration of postprandial walk
Time Frame: From enrollment to delivery, an average of 6 months
Duration of postprandial walk (in minutes)
From enrollment to delivery, an average of 6 months
Sleep duration
Time Frame: From enrollment to delivery, an average of 6 months
Amount of time spent sleeping
From enrollment to delivery, an average of 6 months
Baseline heart rate
Time Frame: From enrollment to delivery, an average of 6 months
Heart rate when not exercising
From enrollment to delivery, an average of 6 months
Maximal heart rate during walks
Time Frame: From enrollment to delivery, an average of 6 months
Maximal heart rate during postprandial walks
From enrollment to delivery, an average of 6 months
Frequency of aerobic exercise per week
Time Frame: From enrollment to delivery, an average of 6 months
Number of times a participant engages in aerobic exercise each week
From enrollment to delivery, an average of 6 months
Mean glucose level
Time Frame: From enrollment to delivery, an average of 6 months
Average blood sugar level
From enrollment to delivery, an average of 6 months
Blood Glucose Excursions
Time Frame: From enrollment to delivery, an average of 6 months
Changes in blood glucose
From enrollment to delivery, an average of 6 months
Fasting blood sugar
Time Frame: From enrollment to delivery, an average of 6 months
Blood sugar following a fast
From enrollment to delivery, an average of 6 months
Total daily insulin dose
Time Frame: From enrollment to delivery, an average of 6 months
The total amount of insulin administered to the participant daily
From enrollment to delivery, an average of 6 months
Rates of fetal demise
Time Frame: From enrollment to delivery, an average of 6 months
Whether fetal death occurs prior to delivery
From enrollment to delivery, an average of 6 months
Rates of fetal growth restriction among participants
Time Frame: From enrollment to delivery, an average of 6 months
When the fetus is considered small for gestational age at any point in pregnancy
From enrollment to delivery, an average of 6 months
Rates of preeclampsia among participants
Time Frame: From enrollment to delivery, an average of 6 months
Occurrence of preeclampsia during pregnancy
From enrollment to delivery, an average of 6 months
Rates of placental abruption among participants
Time Frame: From enrollment to delivery, an average of 6 months
From enrollment to delivery, an average of 6 months
Mode of delivery
Time Frame: From enrollment to delivery, an average of 6 months
Cesarean or vaginal
From enrollment to delivery, an average of 6 months
Number of participants with indication for cesarean delivery
Time Frame: From enrollment to delivery, an average of 6 months
From enrollment to delivery, an average of 6 months
Presence of shoulder dystocia
Time Frame: Duration of delivery, up to 72 hours
Vaginal deliveries
Duration of delivery, up to 72 hours
Quantitative blood loss
Time Frame: From onset of labor to hospital discharge, up to 42 days post-delivery
mL
From onset of labor to hospital discharge, up to 42 days post-delivery
Postpartum hemorrhage
Time Frame: From delivery to hospital discharge, up to 42 days post-delivery
Defined as quantitative blood loss >1000 mL
From delivery to hospital discharge, up to 42 days post-delivery
Occurrence of Infection
Time Frame: From delivery to hospital discharge, up to 42 days
Chorioamnionitis or postpartum endometritis prior to discharge
From delivery to hospital discharge, up to 42 days
Neonatal birth weight
Time Frame: From delivery to hospital discharge, up to 42 days
Grams
From delivery to hospital discharge, up to 42 days
APGAR Scores
Time Frame: From delivery to hospital discharge, up to 1 year
Scored from 0-10, with 10 being the best outcome
From delivery to hospital discharge, up to 1 year
Incidence of Neonatal Infection
Time Frame: From delivery to hospital discharge, up to 1 year
Sepsis, fever, positive cultures, or a suspicious clinical course that warrants antibiotics treatment
From delivery to hospital discharge, up to 1 year
Rates of respiratory distress syndrome amongst participant infants
Time Frame: From delivery to hospital discharge, up to 1 year
From delivery to hospital discharge, up to 1 year
Rates of necrotizing enterocolitis amongst participant infants
Time Frame: From delivery to hospital discharge, up to 1 year
From delivery to hospital discharge, up to 1 year
Rates Neonatal Intensive Care Unit admission amongst participant infants
Time Frame: From deliver to NICU admission, up to 1 year
From deliver to NICU admission, up to 1 year
Days in the NICU
Time Frame: From NICU admission to NICU discharge, up to 1 year
From NICU admission to NICU discharge, up to 1 year
Hemoglobin A1c
Time Frame: At time of randomization, up to 32 weeks gestation
Blood Hemoglobin A1c level
At time of randomization, up to 32 weeks gestation
Hemoglobin A1c
Time Frame: Between 34 and 36 weeks gestation
Blood Hemoglobin A1c levels
Between 34 and 36 weeks gestation
C-peptide
Time Frame: Collected at time of randomization, up to 32 weeks gestation
Blood c-peptide levels
Collected at time of randomization, up to 32 weeks gestation
C-peptide
Time Frame: Between 34 and 36 weeks gestation
Blood c-peptide levels
Between 34 and 36 weeks gestation
Insulin
Time Frame: At time of randomization, up to 32 weeks gestation
Blood insulin levels
At time of randomization, up to 32 weeks gestation
Insulin
Time Frame: Between 34 and 36 weeks gestation
Blood insulin level
Between 34 and 36 weeks gestation
Leptin
Time Frame: At time of randomization, up to 32 weeks gestation
Blood leptin level
At time of randomization, up to 32 weeks gestation
Leptin
Time Frame: Between 34 and 36 weeks gestation
Blood leptin level
Between 34 and 36 weeks gestation
Adipoleptin
Time Frame: At time of randomization, up to 32 weeks gestation
Blood adipoleptin
At time of randomization, up to 32 weeks gestation
Adipoleptin
Time Frame: Between 34 and 36 weeks gestation
Blood adipoleptin level
Between 34 and 36 weeks gestation
Body fat mass
Time Frame: At time of randomization, up to 32 weeks gestation
Mass of body fat determined using bioelectrical impedance analysis
At time of randomization, up to 32 weeks gestation
Body fat mass
Time Frame: Between 34 and 36 weeks gestation
Mass of body fat determined using bioelectrical impedance analysis
Between 34 and 36 weeks gestation
Body fat percentage
Time Frame: At time of randomization, up to 32 weeks gestation
Body fat percentage determined via bioelectrical impedance analysis
At time of randomization, up to 32 weeks gestation
Body fat percentage
Time Frame: Between 34 and 36 weeks gestation
Body fat percentage determined via bioelectrical impedance analysis
Between 34 and 36 weeks gestation
Fat free mass
Time Frame: Time of randomization, up to 32 weeks
Measure of body composition, determined by bioelectrical impedance analysis
Time of randomization, up to 32 weeks
Fat free mass
Time Frame: Between 34 and 36 weeks gestation
Measure of body composition, determined by bioelectrical impedance analysis
Between 34 and 36 weeks gestation
Total body water
Time Frame: At time of randomization, up to 32 weeks gestation
Amount of water in the body, determined by bioelectrical impedance analysis
At time of randomization, up to 32 weeks gestation
Total body water
Time Frame: Between 34 and 36 weeks gestation
Amount of water in the body, determined by bioelectrical impedance analysis
Between 34 and 36 weeks gestation

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.
Eastern Virginia Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

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.
December 1, 2025

Primary Completion (Estimated)

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.
December 1, 2026

Study Completion (Estimated)

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.
December 1, 2026

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 24, 2025

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.
November 18, 2025

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.
November 26, 2025

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 26, 2025

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.
November 18, 2025

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.
November 1, 2025

More Information

Terms related to this study

Keywords

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.
  • 24-06-FB-0155

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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