NCT07250698尚未招募不适用
Postprandial Walks for Glucose Control in Type 2 Diabetes in Pregnancy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 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
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)
- 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)
- Leptin(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)
- Fat free mass(Between 34 and 36 weeks gestation)
- Total body water(Between 34 and 36 weeks gestation)
研究者
Marwan Ma'ayeh
Assistant Professor
Eastern Virginia Medical School
研究点 (2)
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