Influence of an Amino Acid and Chromium Containing Table Water on Glucose Response to a Test Meal in Type 2 Diabetes Patients in a Double Blind Cross - Over Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Area under the curve for Glucose
研究概览
简要总结
It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Early Type 2 Diabetes (i.e. on Metformin or diet only)
- •Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)
- •HbA1c < 7%
- •BMI 28,0-39,9 kg/m²
排除标准
- •Any antidiabetic medication other than metformin
- •Psychiatric Disease
- •Acute Infections
- •Alcohol or drug abuse
- •Malignant tumors or hematologic disorders
- •Heart failure NYHA III-IV
- •Acute coronary syndrome
- •Any macrovascular event within previous 3 months
- •Chronic kidney disease > Stage 3
- •Pregnancy or Lactation
研究组 & 干预措施
Amino Acids, Chromium - Picolinate
Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
干预措施: Amino Acid and chromium-picolinate containing drink (Dietary Supplement)
Amino Acids, Chromium - Picolinate
Verum drink containing the dietary supplements is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
干预措施: Placebo Drink (Dietary Supplement)
Placebo Drink
Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
干预措施: Amino Acid and chromium-picolinate containing drink (Dietary Supplement)
Placebo Drink
Placebo Drink containing aroma only is taken with a test meal. INsulin and glucose response is documented for 180 minutes.
干预措施: Placebo Drink (Dietary Supplement)
结局指标
主要结局
Area under the curve for Glucose
时间窗: 0', 15', 30', 60', 90', 120', 150', 180' post test meal
Area under the curve for glucose will be measured within 180 minutes after a test meal. Blood samples will be drawan at 8 timepoints during 180 minutes after ingestion of the test meal (0', 15', 30', 60', 90', 120', 150', 180').
次要结局
- markers of lipid metabolism(0', 15', 30', 60', 90', 120', 150', 180' post test meal)
- Gut peptide hormones(0', 15', 30', 60', 90', 120', 150', 180' post test meal)
- AUC for insulin(0', 15', 30', 60', 90', 120', 150', 180' post test meal)
- Markers of inflammation(at 0', 15', 30', 60', 90', 120', 150', 180' post test meal)
研究者
Dr. Per Humpert
Privatdozent Dr. Per M. Humpert
Stoffwechselzentrum Rhein - Pfalz