Effect of Premeal Consumption of Protein-enriched, Dietary Fiber-fortified Cereal Bar on Long-term Glycemic Control in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in HbA1c From Baseline
研究概览
简要总结
The aim of this study is to evaluate the effect of premeal protein-enriched bar in long-term glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who intake premeal protein-enriched bar with dietary modification will be compared to those in subjects who only do the dietary modification.
详细描述
Forty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are premeal protein bar with dietary modification group and dietary modification only group. The study will be conducted for 12 weeks for each participants. All participants will receive diabetes diet education. Intervention group will consume protein-enriched bar before each meals (at least twice a day) and control group will follow diabetes diet education without other additional supplements. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, HOMA-IR and HOMA-beta from baseline for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 18.5~35 kg/m2
- •Type 2 diabetes patients
- •Fasting blood glucose ≥ 126 mg/dl or
- •HbA1c ≥ 6.5% or
- •Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin.
排除标准
- •HbA1c < 6.5% or > 10%
- •Subjects using insulin other than basal insulin
- •Subjects who have newly started or have changed anti diabetic drugs within 3 months
- •Subjects who are allergic to grains, nuts, legumes and milk
- •Previous history of gastrointestinal surgery (except for hemorrhoid surgery, appendectomy surgery and hernia surgery)
- •Subjects with chronic unstable disease
- •Subjects with cognitive impairments who are not able to follow the study protocol
- •Females who are pregnant or doing breast feeding
- •Subjects with Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels of higher than 3 times of upper normal ranges
- •Subjects with hemoglobin level of less than 10.0 g/dL
- •Subjects with alcohol addiction or drug abuse
结局指标
主要结局
Change in HbA1c From Baseline
时间窗: 0 week, 12 weeks
次要结局
- Change in Blood High-density Lipoprotein Level From Baseline(0 week, 12 weeks)
- Change in Fasting Blood Glucose Level From Baseline(0 week, 12 weeks)
- Change in Body Weight From Baseline(0 week, 12 weeks)
- Change in Waist Circumference From Baseline(0 week, 12 weeks)
- Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) From Baseline(0 week, 12 weeks)
- Change in Blood Low-density Lipoprotein Level From Baseline(0 week, 12 weeks)
- Change in Blood Triglyceride Level From Baseline(0 week, 12 weeks)
- Change in Homeostatic Model Assessment of β-cell Function (HOMA-beta) From Baseline(0 week, 12 weeks)
研究者
Young Min Cho
Professor
Seoul National University Hospital