NCT05917808招募中不适用
A Food Product for Glucose Management in Gestational Diabetes Mellitus - a Pilot Study
Stoffwechselzentrum Rhein - Pfalz2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年5月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in 2 hour glucose in OGTT
研究概览
简要总结
The goal of this pilot open pre-post clinical trial is to test effects of a wholegrain product in patients with newly diagnosed gestational diabetes. The main question it aims to answer is:
Does the wholegrain product improve glucose tolerance and insulin sensitivity during a 75 g oral glucose tolerance test (OGTT).
Participants will consume product on two consecutive evenings shortly after the first OGTT and will then perform a second OGTT. Researchers will compare the results of the first and second OGTT to see if glucose tolerance improved after consumption of the test product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pathological fasting glucose or OGTT according to WHO-criteria for the diagnosis of gestational diabetes (see Table 1).
- •Agree to maintain consistent dietary habits and physical activity levels for the duration of the study.
- •Willingness to complete questionnaires and follow instructions associated with the study and to perform another OGTT at the clinic in a second visit.
- •Has given voluntary, written, informed consent to participate in the study.
排除标准
- •Type 2 diabetes prior to pregnancy
- •Psychiatric Disease
- •Acute Infections
- •Alcohol or drug abuse
- •Acute diverticulitis
- •Malignant tumors or hematologic disorders
- •Heart failure stages III-IV according to New York Heart Association (NYHA)
- •Acute coronary syndrome
- •Chronic kidney disease > Stage 3 (Kidney Disease Outcomes Quality Initiative - KDOQI)
- •Celiac disease
- •Diagnosed Inflammatory bowel diseases (mainly Crohn´s, Ulcerative colitis)
- •Allergy to ingredients included in the investigational product.
- •Use of antibiotics within 2 weeks of enrollment
- •Use of probiotics within 2 weeks of enrollment
结局指标
主要结局
Change in 2 hour glucose in OGTT
时间窗: 3-7 working days
Change of the 2 hour glucose value in an oral glucose tolerance test
次要结局
- Number of values changing from diabetic to non-diabetic values per patient(3-7 working days)
- Change in plasma insulin 1 hour during OGTT(3-7 working days)
- Change in plasma insulin 2 hour during OGTT(3-7 working days)
- Change of the fasting glucose values(3-7 working days)
- Change in 1h glucose in OGTT(3-7 working days)
- Number of individuals converting from diabetic to non-diabetic OGTT / fasting glucose(3-7 working days)
- Change in plasma insulin fasting(3-7 working days)
- Change in homeostasis model assessment (HOMA) Index between 1st and second OGTT(3-7 working days)
研究者
研究点 (2)
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