An interventional study of Exercise in Pregestational Diabetes and Type 2 Diabetes, sponsored by Eastern Virginia Medical School. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-11-26.
Sponsored by Eastern Virginia Medical School · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
This intervention consists of instructions to walk for 20 minutes after each meal.
Blood Glucose Time in Range
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.
Time frame: Between 34 and 36 weeks gestation.
Duration of postprandial walk
Duration of postprandial walk (in minutes)
Time frame: From enrollment to delivery, an average of 6 months
Sleep duration
Amount of time spent sleeping
Time frame: From enrollment to delivery, an average of 6 months
Baseline heart rate
Heart rate when not exercising
Time frame: From enrollment to delivery, an average of 6 months
Maximal heart rate during walks
Maximal heart rate during postprandial walks
Time frame: From enrollment to delivery, an average of 6 months
Frequency of aerobic exercise per week
Number of times a participant engages in aerobic exercise each week
Time frame: From enrollment to delivery, an average of 6 months
Mean glucose level
Average blood sugar level
Time frame: From enrollment to delivery, an average of 6 months
Blood Glucose Excursions
Changes in blood glucose
Time frame: From enrollment to delivery, an average of 6 months
Fasting blood sugar
Blood sugar following a fast
Time frame: From enrollment to delivery, an average of 6 months
Total daily insulin dose
The total amount of insulin administered to the participant daily
Time frame: From enrollment to delivery, an average of 6 months
Rates of fetal demise
Whether fetal death occurs prior to delivery
Time frame: From enrollment to delivery, an average of 6 months
Rates of fetal growth restriction among participants
When the fetus is considered small for gestational age at any point in pregnancy
Time frame: From enrollment to delivery, an average of 6 months
Rates of preeclampsia among participants
Occurrence of preeclampsia during pregnancy
Time frame: 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
Mode of delivery
Cesarean or vaginal
Time frame: 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
Presence of shoulder dystocia
Vaginal deliveries
Time frame: Duration of delivery, up to 72 hours
Quantitative blood loss
mL
Time frame: From onset of labor to hospital discharge, up to 42 days post-delivery
Postpartum hemorrhage
Defined as quantitative blood loss \>1000 mL
Time frame: From delivery to hospital discharge, up to 42 days post-delivery
Occurrence of Infection
Chorioamnionitis or postpartum endometritis prior to discharge
Time frame: From delivery to hospital discharge, up to 42 days
Neonatal birth weight
Grams
Time frame: From delivery to hospital discharge, up to 42 days
APGAR Scores
Scored from 0-10, with 10 being the best outcome
Time frame: From delivery to hospital discharge, up to 1 year
Incidence of Neonatal Infection
Sepsis, fever, positive cultures, or a suspicious clinical course that warrants antibiotics treatment
Time frame: 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
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
Blood Hemoglobin A1c level
Time frame: At time of randomization, up to 32 weeks gestation
Hemoglobin A1c
Blood Hemoglobin A1c levels
Time frame: Between 34 and 36 weeks gestation
C-peptide
Blood c-peptide levels
Time frame: Collected at time of randomization, up to 32 weeks gestation
C-peptide
Blood c-peptide levels
Time frame: Between 34 and 36 weeks gestation
Insulin
Blood insulin levels
Time frame: At time of randomization, up to 32 weeks gestation
Insulin
Blood insulin level
Time frame: Between 34 and 36 weeks gestation
Leptin
Blood leptin level
Time frame: At time of randomization, up to 32 weeks gestation
Leptin
Blood leptin level
Time frame: Between 34 and 36 weeks gestation
Adipoleptin
Blood adipoleptin
Time frame: At time of randomization, up to 32 weeks gestation
Adipoleptin
Blood adipoleptin level
Time frame: Between 34 and 36 weeks gestation
Body fat mass
Mass of body fat determined using bioelectrical impedance analysis
Time frame: At time of randomization, up to 32 weeks gestation
Body fat mass
Mass of body fat determined using bioelectrical impedance analysis
Time frame: Between 34 and 36 weeks gestation
Body fat percentage
Body fat percentage determined via bioelectrical impedance analysis
Time frame: At time of randomization, up to 32 weeks gestation
Body fat percentage
Body fat percentage determined via bioelectrical impedance analysis
Time frame: Between 34 and 36 weeks gestation
Fat free mass
Measure of body composition, determined by bioelectrical impedance analysis
Time frame: Time of randomization, up to 32 weeks
Fat free mass
Measure of body composition, determined by bioelectrical impedance analysis
Time frame: Between 34 and 36 weeks gestation
Total body water
Amount of water in the body, determined by bioelectrical impedance analysis
Time frame: At time of randomization, up to 32 weeks gestation
Total body water
Amount of water in the body, determined by bioelectrical impedance analysis
Time frame: Between 34 and 36 weeks gestation
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
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Eastern Virginia Medical School