Metabolic Effects of Whey Compounds in Patients With Diabetes Mellitus Type 2.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Difference in iAUC for insulin between WHE and speWHE
研究概览
简要总结
The main objective of our study is to investigate the metabolic effects of a i) ordinary whey protein (WHE) and ii) a specific whey protein fraction (speWHE) when the interventions are ingested by patients with type 2 diabetes 30 minutes prior to an oral glucose tolerance test (OGTT). We will also investigate the glucose response when the patients ingest the interventions at home in their own environment 30 minutes before breakfast and dinner (2days) and also monitor glucose levels without interventions (2 days).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Type 2 diabetes (T2D) diagnosis
- •No medical treatment or metformin/sulfonylureas(SU) alone in the treatment of T2D
- •No daily use of protein drinks
- •Hba1c between 40 mmol/mol and 69 mmol/mol
- •20 kg/m2 < BMI < 35 kg/m2
- •Screening blood test: 1200 pmol/l > C-peptid > 370 pmol/l
排除标准
- •Other diabetes medication than metformin/SU (e.g. insulin, GLP-1 analog, DPP-4 inhibitor, SGLT2-inhibitor)
- •Affected screening blood test assessed by the primary investigator(PI)/sponsor
- •Does not understand or speak danish
- •Milk allergy
- •PI finds the patient not fit (e.g. mental illness, too nervous or other)
研究组 & 干预措施
WHE (regular whey protein)
Regular whey protein. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment.
干预措施: WHE (Dietary Supplement)
speWHE (specific whey protein compound)
Specific whey protein compound. The intervention will be ingested 30 min. prior to an OGTT (3 hours). The intervention will also be ingested 30 min prior to breakfast and dinner for 2 days in the patient's own environment.
干预措施: speWHE (Dietary Supplement)
结局指标
主要结局
Difference in iAUC for insulin between WHE and speWHE
时间窗: OGTT, 3 hours.
Difference in iAUC for insulin between WHE and speWHE
次要结局
- Differences in iAUC and concentration differences for C-peptid(OGTT 3 hours)
- Differences in iAUC and concentration differences for FFA(OGTT 3 hours)
- Activity measurements(5 days)
- continuous glucose measurement (CGM)(5 days)
- Differences in iAUC and concentration differences for GIP(OGTT 3 hours)
- Differences in iAUC and concentration differences for GLP-1(OGTT 3 hours)
- Differences in iAUC and concentration differences for glucagon(OGTT 3 hours)
- Differences in iAUC and concentration differences for glucose(OGTT 3 hours)