NCT01987674终止1 期
Impact of a Pre-meal Protein Drink on Metabolic Markers and Glycemic Control in Patients With Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The purpose of this study is to investigate if a pre-meal drink containing proteins can positively influence glycaemic control in patients with type 2 diabetes mellitus. Comparison with a placebo is included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed type 2 diabetes mellitus according to WHO criteria (1999)
- •age between 30-80 years
- •non well controlled diabetes with HbA1c-levels above 62 mmol/mol
排除标准
- •pregnant or risk of becoming pregnant
- •severe disease
- •psychological disease, dementia or mental disability that makes it impossible to retrieve informed consent of participation
- •liver disease
- •kidney malfunction (GFR <60 or aspartate transaminase (ASAT)/alanine transaminase (ALT) two times higher than the normal interval
研究组 & 干预措施
Pre-meal protein drink
Experimental
A dose of 100 ml is taken just before breakfast, lunch and dinner.
干预措施: Pre-meal protein drink (Dietary Supplement)
Water drink
Placebo Comparator
A dose of 100 ml is taken just before breakfast, lunch and dinner.
干预措施: Water drink (Other)
结局指标
主要结局
HbA1c
时间窗: 16 weeks
Glycated hemoglobin
次要结局
- Postprandial glycemia(16 weeks)
研究者
Elin Östman
Associate professor
Lund University
研究点 (1)
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