Postprandial Walks for Glucose Control in Type 2 Diabetes in Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Blood Glucose Time in Range
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exercise (Behavioral)
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.
结局指标
主要结局
Blood Glucose Time in Range
时间窗: 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.
次要结局
- Hemoglobin A1c(At time of randomization, up to 32 weeks gestation)
- C-peptide(Collected at time of randomization, up to 32 weeks gestation)
- Insulin(At time of randomization, up to 32 weeks gestation)
- Leptin(At time of randomization, up to 32 weeks gestation)
- Adipoleptin(At time of randomization, up to 32 weeks gestation)
- Body fat mass(At time of randomization, up to 32 weeks gestation)
- Body fat percentage(At time of randomization, up to 32 weeks gestation)
- Fat free mass(Time of randomization, up to 32 weeks)
- Total body water(At time of randomization, up to 32 weeks gestation)
- Quantitative blood loss(From onset of labor to hospital discharge, up to 42 days post-delivery)
- Leptin(Between 34 and 36 weeks gestation)
- Adipoleptin(Between 34 and 36 weeks gestation)
- Body fat mass(Between 34 and 36 weeks gestation)
- Body fat percentage(Between 34 and 36 weeks gestation)
- Fat free mass(Between 34 and 36 weeks gestation)
- Total body water(Between 34 and 36 weeks gestation)
- Duration of postprandial walk(From enrollment to delivery, an average of 6 months)
- Sleep duration(From enrollment to delivery, an average of 6 months)
- Baseline heart rate(From enrollment to delivery, an average of 6 months)
- Maximal heart rate during walks(From enrollment to delivery, an average of 6 months)
- Frequency of aerobic exercise per week(From enrollment to delivery, an average of 6 months)
- Mean glucose level(From enrollment to delivery, an average of 6 months)
- Blood Glucose Excursions(From enrollment to delivery, an average of 6 months)
- Fasting blood sugar(From enrollment to delivery, an average of 6 months)
- Total daily insulin dose(From enrollment to delivery, an average of 6 months)
- Rates of fetal demise(From enrollment to delivery, an average of 6 months)
- Rates of fetal growth restriction among participants(From enrollment to delivery, an average of 6 months)
- Rates of preeclampsia among participants(From enrollment to delivery, an average of 6 months)
- 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)
- 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)
- Postpartum hemorrhage(From delivery to hospital discharge, up to 42 days post-delivery)
- Occurrence of Infection(From delivery to hospital discharge, up to 42 days)
- Neonatal birth weight(From delivery to hospital discharge, up to 42 days)
- APGAR Scores(From delivery to hospital discharge, up to 1 year)
- Incidence of Neonatal Infection(From delivery to hospital discharge, up to 1 year)
- Rates of respiratory distress syndrome amongst participant infants(From delivery to hospital discharge, up to 1 year)
- Rates of necrotizing enterocolitis amongst participant infants(From delivery to hospital discharge, up to 1 year)
- 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(Between 34 and 36 weeks gestation)
- C-peptide(Between 34 and 36 weeks gestation)
- Insulin(Between 34 and 36 weeks gestation)
研究者
Marwan Ma'ayeh
Assistant Professor
Eastern Virginia Medical School