GRAPE-GDM Prospective Comperative Trial - Grape Juice as a Replacement Drink for Gestational Diabetes Screening
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Blood glucose concentration after test beverage
研究概览
简要总结
Study Type: Observational, prospective, multicenter comparative study
Primary Purpose: The goal of this study is to evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening in pregnant individuals at 24-28 weeks of gestation.
Main Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Comparison Group:
Researchers will compare the standard GCT (50g glucola drink) with the alternative GCT (500 ml grape juice containing 50g sugar). Each participant will undergo both tests, serving as her own control, to assess differences in glucose measurements and patient preferences.
Participant Tasks:
Participants will:
- Undergo two glucose challenge tests (GCT): Standard GCT (50g glucola) at their health maintenance organization (HMO) or hospital.
Alternative GCT (500 ml grape juice) during a scheduled visit or hospitalization.
- Have blood drawn one hour after each test for glucose measurement.
- Complete a questionnaire assessing satisfaction and preference between the two methods.
- Provide follow-up information if they require additional testing (e.g., 100g OGTT).
详细描述
Study Type: Prospective, observational, multicenter comparative study Primary Purpose: To evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening, with the goal of improving patient compliance and satisfaction.
Participant Population: Pregnant individuals at 24-28 weeks of gestation, undergoing routine glucose challenge testing (GCT). Participants will be recruited from Maternal-Fetal Medicine (MFM) clinics, prenatal maternal wards, and social media outreach.
Main Research Questions:
Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening?
Study Design & Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Pregnant individuals scheduled for routine GCT at 24-28 weeks. Well-dated pregnancy (confirmed first-trimester ultrasound). Willingness to comply with study protocol.
排除标准
- •High-risk individuals requiring direct 100g OGTT (e.g., prior GDM, BMI >40, PCOS).
- •Intolerance to the alternative drink. Gastrointestinal conditions affecting glucose absorption such as active bowel disiease.
- •Recent corticosteroid administration for fetal lung maturity after standard GCT.
研究组 & 干预措施
grape juice
Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar).
Control Group: Each participant serves as her own control by completing both tests in a randomized order.
干预措施: Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load. (Other)
结局指标
主要结局
Blood glucose concentration after test beverage
时间窗: one hour from injestion of the drink
Venous plasma glucose ( measured at 60 minutes after each beverage
次要结局
- Participant satisfaction with glucose drink(One hour after ingestion of the glucose drink.)
- Participant preference for glucose challenge test drink(One hour after ingestion of the glucose drink.)
- Adverse events following glucose drink ingestion(One hour after ingestion of the glucose drink.)