Early Postpartum Treatment of Gestational Diabetes With Weight Loss and Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Incidence of glucose intolerance
研究概览
简要总结
The overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (GDM), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.
详细描述
The objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of GDM will:
- decrease body weight and
- reduce the rate of metabolic abnormalities, 12 months after delivery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women are required to be enrolled (provided written consent for participation) in the COPSS-GDM study and therefore have met the following inclusion criteria:
- •Postpartum Women ≥18 years to 45 years (inclusive) of age who experienced GDM during index pregnancy
- •English-speaking
排除标准
- •Exclusion Criteria:
- •Women enrolled in COPSS-GDM will be excluded if they met the following criteria:
- •Medical Exclusion Criteria
- •History or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer
- •Regular use of medications for weight control or psychosis
- •Current use of medication to treat diabetes Psychiatric and Behavioral Exclusion Criteria
- •History or clinical manifestation of any eating disorder
- •History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years Other Exclusion Criteria
- •Pregnancy or pregnancy planned during the coming year
- •Unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period
结局指标
主要结局
Incidence of glucose intolerance
时间窗: 8 Months
To examine the incidence of glucose abnormalities (impaired fasting glucose, impaired glucose tolerance, type 2 diabetes) and health outcomes (changes in body fat, waist circumference and blood lipids)in women with a history of gestational diabetes, 12 months postpartum.
次要结局
- Weight loss(8 months)
研究者
Leanne Redman
Principle Investigator
Pennington Biomedical Research Center