Eastern Virginia Medical School, Macon and Joan Brock Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, 23507, United States
Not Yet Recruiting
NCT Number: NCT07250698
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year–50 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Exercise
BehavioralThis intervention consists of instructions to walk for 20 minutes after each meal.
Primary outcomes
-
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.
Secondary outcomes
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Duration of postprandial walk
Time frame: From enrollment to delivery, an average of 6 months
Duration of postprandial walk (in minutes)
-
Sleep duration
Time frame: From enrollment to delivery, an average of 6 months
Amount of time spent sleeping
-
Baseline heart rate
Time frame: From enrollment to delivery, an average of 6 months
Heart rate when not exercising
-
Maximal heart rate during walks
Time frame: From enrollment to delivery, an average of 6 months
Maximal heart rate during postprandial walks
-
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
-
Mean glucose level
Time frame: From enrollment to delivery, an average of 6 months
Average blood sugar level
-
Blood Glucose Excursions
Time frame: From enrollment to delivery, an average of 6 months
Changes in blood glucose
-
Fasting blood sugar
Time frame: From enrollment to delivery, an average of 6 months
Blood sugar following a fast
-
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
-
Rates of fetal demise
Time frame: From enrollment to delivery, an average of 6 months
Whether fetal death occurs prior to delivery
-
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
-
Rates of preeclampsia among participants
Time frame: From enrollment to delivery, an average of 6 months
Occurrence of preeclampsia during pregnancy
-
Rates of placental abruption among participants
Time frame: 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
-
Number of participants with indication for cesarean delivery
Time frame: From enrollment to delivery, an average of 6 months
-
Presence of shoulder dystocia
Time frame: Duration of delivery, up to 72 hours
Vaginal deliveries
-
Quantitative blood loss
Time frame: From onset of labor to hospital discharge, up to 42 days post-delivery
mL
-
Postpartum hemorrhage
Time frame: From delivery to hospital discharge, up to 42 days post-delivery
Defined as quantitative blood loss >1000 mL
-
Occurrence of Infection
Time frame: From delivery to hospital discharge, up to 42 days
Chorioamnionitis or postpartum endometritis prior to discharge
-
Neonatal birth weight
Time frame: From delivery to hospital discharge, up to 42 days
Grams
-
APGAR Scores
Time frame: From delivery to hospital discharge, up to 1 year
Scored from 0-10, with 10 being the best outcome
-
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
-
Rates of respiratory distress syndrome amongst participant infants
Time frame: 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
-
Rates Neonatal Intensive Care Unit admission amongst participant infants
Time frame: 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
-
Hemoglobin A1c
Time frame: At time of randomization, up to 32 weeks gestation
Blood Hemoglobin A1c level
-
Hemoglobin A1c
Time frame: Between 34 and 36 weeks gestation
Blood Hemoglobin A1c levels
-
C-peptide
Time frame: Collected at time of randomization, up to 32 weeks gestation
Blood c-peptide levels
-
C-peptide
Time frame: Between 34 and 36 weeks gestation
Blood c-peptide levels
-
Insulin
Time frame: At time of randomization, up to 32 weeks gestation
Blood insulin levels
-
Insulin
Time frame: Between 34 and 36 weeks gestation
Blood insulin level
-
Leptin
Time frame: At time of randomization, up to 32 weeks gestation
Blood leptin level
-
Leptin
Time frame: Between 34 and 36 weeks gestation
Blood leptin level
-
Adipoleptin
Time frame: At time of randomization, up to 32 weeks gestation
Blood adipoleptin
-
Adipoleptin
Time frame: Between 34 and 36 weeks gestation
Blood adipoleptin level
-
Body fat mass
Time frame: At time of randomization, up to 32 weeks gestation
Mass of body fat determined using bioelectrical impedance analysis
-
Body fat mass
Time frame: Between 34 and 36 weeks gestation
Mass of body fat determined using bioelectrical impedance analysis
-
Body fat percentage
Time frame: At time of randomization, up to 32 weeks gestation
Body fat percentage determined via bioelectrical impedance analysis
-
Body fat percentage
Time frame: Between 34 and 36 weeks gestation
Body fat percentage determined via bioelectrical impedance analysis
-
Fat free mass
Time frame: Time of randomization, up to 32 weeks
Measure of body composition, determined by bioelectrical impedance analysis
-
Fat free mass
Time frame: Between 34 and 36 weeks gestation
Measure of body composition, determined by bioelectrical impedance analysis
-
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
-
Total body water
Time frame: Between 34 and 36 weeks gestation
Amount of water in the body, determined by bioelectrical impedance analysis
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Eastern Virginia Medical School
Other
Registry information
Official study title
Postprandial Walks for Glucose Control in Type 2 Diabetes in Pregnancy
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 26, 2025
- Registry last updated
- Nov 26, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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