Effect of Qigong on Gestational Diabetes Mellitus：A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Fasting blood glucose
研究概览
简要总结
The goal of this clinical trial is to learn about in women with gestational diabetes's health conditions.
The main question[s] it aims to answer are:
- Can Qigong control blood glucose in women with gestational diabetes?
- Can Qigong improve mood and sleep in women with gestational diabetes? Participants will required to follow the research team for 3 months of qigong practice。 If there is a comparison group: Researchers will compare Qigong groups to see if Qigong's effects.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •20 years old≤ age ≤ 40 years old;
- •Those with clear awareness, acceptable reading and language expression skills, and barrier-free communication;
- •singleton pregnancy;
- •gestational age between 24 and 28 weeks, with the upper limit of gestational age set at 28 weeks at the time of inclusion to allow for at least 8 weeks of intervention;
- •Body mass index (BMI) is lower than 40;
- •Agree to participate in this project and sign the informed consent form.
排除标准
- •Those with previous GDM and diabetes;
- •Artificial insemination;
- •Those with serious obstetric complications and contraindications;
- •Participants in other planned and supervised exercise programs or researchers during the study.
结局指标
主要结局
Fasting blood glucose
时间窗: Average peripheral fasting blood glucose measured one week prior to participant enrollment. Fasting blood glucose measured in the first week after the end of 12 weeks of intervention.
If the blood glucose level is between 4.0 and 5.4 mmol/L, the result is normal. If the fasting blood glucose level is between 5.5-6.9 mmol/L, the condition is called prediabetes. Diabetes refers to blood sugar greater than 8.5 mmol/L.
2-h postprandial plasma glucose
时间窗: Average postprandial blood glucose measured in the week prior to study participant enrollment. Average postprandial 2-hour postprandial peripheral capillary blood glucose measured in the first week after the end of 12 weeks of intervention.
less than 7.8mmol/L. When the blood glucose is 7.8\~11.1 mmol/L 2 hours after meals, it can be diagnosed as impaired or impaired glucose tolerance.
次要结局
- Pittsburgh sleep quality index,PSQI(Weeks 0 and 13)
- Self-Rating Depression Scale，SDS(Weeks 0 and 13)
- Self-Rating Anxiety Scale, SAS(Weeks 0 and 13)
研究者
Chen Chaoyang
Shanghai Qigong Research Institute Trainee researcher
Shanghai University of Traditional Chinese Medicine