The Effects of Premeal Consumption of Protein-enriched Bar on Blood Glucose Level and Secretion of Hormones in Healthy Adults and Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- plasma glucose level after breakfast
研究概览
简要总结
The aim of this study is to explore premeal protein-enriched bar effect in postprandial glucose levels and concentration of plasma incretin hormones [glucagon-like peptide 1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP)] in healthy subjects and those with type 2 diabetes.
详细描述
Fifteen healthy subjects and fifteen subjects with type 2 diabetes treated by diet and/or metformin, SU, DPP4 inhibitors will be recruited. Every subject will studied on 2 separate days in random order with 1-2 week intervals. These participants will consume protein enriched bar followed by a standardized high-glycemic-index breakfast in a hospital setting or breakfast followed protein enriched bar in a cross-over fashion. Blood sampling will be done at the moment of start of breakfast (0 min) and then 10, 20, 30, 60, 90, 120, 150, 180 min. Plasma glucose levels, total/active GLP-1, GIP, insulin, C-peptide, glucagon will be measured. Incremental area under the curve (iAUC) of glucose level and hormone from 0 min to 180 min will be calculated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 18.5~35 kg/m2
- •Healthy volunteer:
- •never diagnosed by diabetes and
- •fasting plasma glucose <=100mg/dl and HbA1c <6.0%
- •participants with diabetes
- •diagnosed by diabetes
- •if treated by diet, HbA1c 6.0~9.0%
- •if treated by metformin or SU, HbA1c 6.0~10.0%
- •if treated by DPP4 inhibitor HbA1c 6.0~9.0%
排除标准
- •Those who diagnosed by Type 1 diabetes
- •History of DKA
- •History of insulin therapy
- •Allergy to wheat, flour, nuts, milk
- •Pregnancy/lactation
- •AST or ALT >2.5 times of upper normal reference range
- •eGFR <30 mL/min/1.73m2
- •Hb <10g/dl
- •History of GI surgery (except hemorrhoidectomy, appendectomy)
结局指标
主要结局
plasma glucose level after breakfast
时间窗: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
Area under the curve (AUC) of plasma glucose level after breakfast
时间窗: -30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min
次要结局
- plasma GIP level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- Area under the curve of plasma GIP level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- plasma insulin level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- Area under the curve of plasma C-peptide level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- Area under the curve of plasma total/active GLP-1 level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- plasma glucagon level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- plasma total/active GLP-1 level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- Area under the curve of plasma insulin level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- plasma C-peptide level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)
- Area under the curve of plasma glucagon level after breakfast(-30 min, 0(breakfast), 10, 20, 30, 60, 90, 120, 150, 180min)