Lifestyle and Genetic Factors on Diabetes Risk in Women With GDM After Delivery: Tianjin Gestational Diabetes Prevention Program (TGDPP)
试验速览
- 阶段
- 不适用
- 入组人数
- 2,526
- 试验地点
- 1
- 主要终点
- incident type 2 diabetes
研究概览
简要总结
A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 and their children have and continues to be randomly assigned to either the intervention group or the control group. A total of 83 women with prior GDM and newly diagnosed diabetes at baseline survey have the nine-month lifestyle intervention program. GDM women in the intervention group will have five consulting sessions with a dietician during the first year and two sessions during the second year. The intervention group are given detailed advice about how to achieve the five goals of the intervention. The primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes (T2D) in women with prior GDM. The second aim will test gene-intervention interactions through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation to metabolic traits for T2D in GDM women. The third aim will evaluate the effects of the nine-month lifestyle intervention program on cardiovascular risk factors in women with prior GDM and newly diagnosed diabetes. The forth aim will assess if a lifestyle intervention targeting both GDM mothers and their offspring can greatly improve offspring's cardimetablic risk (body weight, glucose and lipid metabolism).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Age < 20 and ≥ 50 years
- •Newly diagnosed diabetes in the screening visit
- •The presence of any chronic diseases that could seriously reduce their life expectancy or their ability to participate in the trial
- •Unable or unwilling to give informed consent or communicate with study staff
- •Currently pregnant, or planning to become pregnant in the next four years
研究组 & 干预措施
Lifestyle counseling
The women in the intervention group will be given detailed advice about how to achieve the six evidence-based goals of the intervention,7-9 including: 1) reduction in 5-10% of initial body weight in women with body mass index (BMI) ≥24 kg/m2 through the reduction of at least 10% of total calories of their normal meals, 2) total fat intake <30% of energy consumed, 3) carbohydrate intake 55-65% of energy consumed, 4) fiber intake 20-30g per day, and 5) moderate or vigorous exercise for at least 30 min daily, seven days each week.
干预措施: Lifestyle intervention (Behavioral)
Control
the subjects in the control group had been educated regarding general principles of healthy lifestyle that benefits T2D and obesity prevention, and also informed about the current evidence showing that the lifestyle intervention is effective in women at high risk for T2D during the "run-in" period.
结局指标
主要结局
incident type 2 diabetes
时间窗: during 4-year follow-up
cardimetablic risk
时间窗: During 4-year follow-up
Children in Aim 4
Cardiovascular risk factors
时间窗: 9 month
Patients with newly diagnosed diabetes in Aim 3
次要结局
- approximately 40 SNPs(during 4-year follow-up)
研究者
HunKun Liu
Project co-investigator
Tianjin Women and Children's Health Center