Can Whey Protein Improve Glycemic Control in Type 2 Diabetes?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Blood Glucose Level
研究概览
简要总结
The purpose of this study is to investigate whether intake of protein supplement just before meals lowers the blood sugar levels after the meals. It is believe that pre-meal administration of a high-protein supplement can effectively improve glycemic control in type 2 diabetes (DM).
详细描述
11.3% of the population aged 20 years or older (25.6 million individuals) has diabetes. In the population aged 65 years or older, the prevalence of diabetes reaches to 26.9%.
Type 2 DM is caused by insulin resistance accompanied by insufficient compensatory insulin response. Therefore insulin secretagogues are a significant component of the therapeutic armamentarium. Insulin secretagogues, such as sulphonylureas and meglitinides, are routinely prescribed to lower post prandial glucose levels in type 2 DM. However, these medications are cleared by the liver and the kidneys and cannot be used in the presence of relevant co-morbidities. These medicines can also cause side effects, including hypoglycemia. Limitations of these medicines are likely to lead diabetic patients and their health care providers to seek alternate methods to treat postprandial hyperglycemia. Thus, our research which aims to identify an alternate insulin secretagogue is important and timely.
Whey protein (WP), a rich source of essential and branch chain (BC) amino acids (AA), is a potent insulin secretagogue. Although it is well known that protein and/or AA intakes stimulate insulin secretion, protein supplements are not being used clinically in order to lower post-prandial glycemia. WP can be a satisfactory alternative to the pharmaceutical insulin secretagogues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women with type 2 DM; age: 25 to 70y; BMI: 25 - 40 kg/m2; on no drug treatment or on metformin alone; HgBA1 6.5 - 8.5%; urinary microalbumin < 30 mg/g cr.
排除标准
- •Systemic disease (liver, renal, untreated hypothyroidism, etc); in the last 2 mo: > 5% weight change, smoking, alcohol intake > 4 /wk; restricted diets; medications or herbals affecting insulin secretion/sensitivity . Pregnant women, prisoners, individuals who cannot provide informed consent.
结局指标
主要结局
Blood Glucose Level
时间窗: each day up to 3 months
次要结局
- Change in 24 hour urine C-peptide excretion level(baseline and 1 month up to 3 months)
- Change in Weight(1 month up to 3 months)
- Change in Body Mass Index (BMI)(1 month up to 3 months)
- Change in vital signs(1 month up to 3 months)
- Change in DEXA(baseline and 1 month up to 3 months)
- Change in Free fatty acids (FFA) levels(baseline and 1 month up to 3 months)
- Change in Lipid levels(baseline and 1 month up to 3 months)
- Change in GLP-1 levels(baseline and 1 month up to 3 months)
- Change in hs-CRP levels(baseline and 1 month up to 3 months)
- Change in Urine glucose level(baseline and 1 month up to 3 months)
- Change in Glycated hemoglobin (HgBA1C) level(baseline and 1 month up to 3 months)