NCT04622722已完成不适用
Efficacy and Safety of Diabetes-specific Formula in Patients With Type 2 Diabetes Mellitus
Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年8月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 2-hour postprandial glucose
研究概览
简要总结
Hypothesis: the diabetes-specific formula Nutren diabetes provides better postprandial glucose control in patients with type 2 diabetes when compared to the isocaloric diet.
详细描述
This study is an open label, randomized controlled cross-over study
Research objectives:
- To study the efficacy of diabetes-specific formula (Nutren Diabetes) in comparison with an isocaloric diet in the aspect of postprandial blood glucose and insulin response (baseline, 30, 60 and 120 minute).
- To study the safety and tolerance of a diabetes-specific formula compared with an isocaloric diet in patients with type 2 diabetes mellitus
Statistical analysis method
- Descriptive statistics: categorical data will be summarized as number and percentage, continuous data with normal distribution will be presented as means and standard deviations, and continuous data with non-normal distribution will be summarized as median, minimum and maximum.
- Inferential statistics: Repeated Measure ANOVA from analyzing the difference of means from measuring fasting glucose and insulin more than two times.
- Inferential statistics: Paired T-Test or Wilcoxon Matched pairs Signed Rank Test derived by analyzing the comparison between the means of two dependent groups.
- Report of the difference between two categories by the difference of means with 95% Confidence Interval
- Number of participant (subjects) and criteria for participation 30 participants by calculation formula of Frison and Pocock (1992) with STATA program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DM type 2, HbA1C < 9% FPG < 180 mg/dl
- •Aged between 18- 70 years.
- •Participants must have stable body weight (+/- not over 5%) for the past six months.
- •Participants must control their diabetes by diet control or taking diabetes medicine without medicine dose adjustment during the period of the research.
- •Participants are willing to participate in the research and sign written consent form.
排除标准
- •Participants receive insulin hormone and GPL-1 agonist injection.
- •GFR < 30 ml/min/1.73 m2
- •Participants have decompensated liver cirrhosis or alcoholism or drug abuse record.
- •Participants have record of allergy to any ingredients in diabetes-specific formula,soybean milk or bologna and mayonnaise sandwich.
- •Participants decline to participate
结局指标
主要结局
2-hour postprandial glucose
时间窗: Change form baseline blood glucose level at 30,60, and 120 min.
The primary outcome will be the difference of 2-hour postprandial glucose between group A and group B
次要结局
- Area under the curve of postprandial plasma insulin (AUC insulin 0-120 min)(Postprandial plasma insulin response at 0, 30, 60,120 min)
- Area under the curve of postprandial plasma glucose (AUC glucose 0-120 min)(Time Frame: Postprandial blood glucose response at 0, 30, 60,120 min)
- Gastrointestinal tolerance(7 days prior to the treatment phase.)
研究者
研究点 (2)
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