Pregestational Diabetes, Type 2 Diabetes
Conditions
Keywords
exercise, continuous glucose monitoring
Brief summary
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.
Interventions
BEHAVIORALExercise
This intervention consists of instructions to walk for 20 minutes after each meal.
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Glucose Time in Range | 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
| Measure | Time frame | Description |
|---|---|---|
| Rates Neonatal Intensive Care Unit admission amongst participant infants | From deliver to NICU admission, up to 1 year | — |
| Days in the NICU | From NICU admission to NICU discharge, up to 1 year | — |
| Hemoglobin A1c | At time of randomization, up to 32 weeks gestation | Blood Hemoglobin A1c level |
| C-peptide | Collected at time of randomization, up to 32 weeks gestation | Blood c-peptide levels |
| Insulin | At time of randomization, up to 32 weeks gestation | Blood insulin levels |
| Duration of postprandial walk | From enrollment to delivery, an average of 6 months | Duration of postprandial walk (in minutes) |
| Sleep duration | From enrollment to delivery, an average of 6 months | Amount of time spent sleeping |
| Baseline heart rate | From enrollment to delivery, an average of 6 months | Heart rate when not exercising |
| Maximal heart rate during walks | From enrollment to delivery, an average of 6 months | Maximal heart rate during postprandial walks |
| Frequency of aerobic exercise per week | From enrollment to delivery, an average of 6 months | Number of times a participant engages in aerobic exercise each week |
| Mean glucose level | From enrollment to delivery, an average of 6 months | Average blood sugar level |
| Blood Glucose Excursions | From enrollment to delivery, an average of 6 months | Changes in blood glucose |
| Fasting blood sugar | From enrollment to delivery, an average of 6 months | Blood sugar following a fast |
| Total daily insulin dose | From enrollment to delivery, an average of 6 months | The total amount of insulin administered to the participant daily |
| Rates of fetal demise | From enrollment to delivery, an average of 6 months | Whether fetal death occurs prior to delivery |
| Rates of fetal growth restriction among participants | 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 necrotizing enterocolitis amongst participant infants | From delivery to hospital discharge, up to 1 year | — |
| Adipoleptin | At time of randomization, up to 32 weeks gestation | Blood adipoleptin |
| Rates of placental abruption among participants | From enrollment to delivery, an average of 6 months | — |
| Mode of delivery | From enrollment to delivery, an average of 6 months | Cesarean or vaginal |
| Number of participants with indication for cesarean delivery | From enrollment to delivery, an average of 6 months | — |
| Presence of shoulder dystocia | Duration of delivery, up to 72 hours | Vaginal deliveries |
| Quantitative blood loss | From onset of labor to hospital discharge, up to 42 days post-delivery | mL |
| Postpartum hemorrhage | From delivery to hospital discharge, up to 42 days post-delivery | Defined as quantitative blood loss \>1000 mL |
| Occurrence of Infection | From delivery to hospital discharge, up to 42 days | Chorioamnionitis or postpartum endometritis prior to discharge |
| Neonatal birth weight | From delivery to hospital discharge, up to 42 days | Grams |
| APGAR Scores | From delivery to hospital discharge, up to 1 year | Scored from 0-10, with 10 being the best outcome |
| Incidence of Neonatal Infection | 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 | From delivery to hospital discharge, up to 1 year | — |
| Leptin | At time of randomization, up to 32 weeks gestation | Blood leptin level |
| Body fat mass | At time of randomization, up to 32 weeks gestation | Mass of body fat determined using bioelectrical impedance analysis |
| Body fat percentage | At time of randomization, up to 32 weeks gestation | Body fat percentage determined via bioelectrical impedance analysis |
| Fat free mass | Time of randomization, up to 32 weeks | Measure of body composition, determined by bioelectrical impedance analysis |
| Total body water | At time of randomization, up to 32 weeks gestation | Amount of water in the body, determined by bioelectrical impedance analysis |
| Rates of preeclampsia among participants | From enrollment to delivery, an average of 6 months | Occurrence of preeclampsia during pregnancy |
Countries
United States
Contacts
Primary ContactMarwan Ma'ayeh, MD
Outcome results
None listed