Effect of Organic Naked Oat With Whole Germ on Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 445
- 试验地点
- 2
- 主要终点
- change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection
研究概览
简要总结
Dietary modification is of great essential for the prevention and treatment of type 2 diabetes mellitus. Common oat (Avena sativa L.) and its products showed a great potential benefits on NCDs including type 2 diabetes mellitus. But data about such effects of naked oat (Avena nuda L.) is still unavailable. The investigators aimed to examine the effects of organic naked oat with whole germ (ONOG) plus diet on patients with type 2 diabetes.
After a pre-study with healthy adults, a randomized, single-blinded, multi-arm parallel trial of 30 days would be carried out in adults of 50-65 years old with type 2 diabetes. Participants would be randomly assigned to one of the four following groups: usual care group (only basic health advice, no other interventions), diet group (systematic education, structured dietary), 50g-ONOG plus diet group (all the interventions of diet group plus replacement of 50g ONOG per day) and 100g-ONOG plus diet group. A regular follow-up for years would be carried out to predict the long-term effects of ONOG plus diet intervention on patients with type 2 diabetes.
The investigators hypothesized that ONOG combined with diet would have better effects on glycaemia and insulin resistance control in addition to those yielded by diet or usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all adults aged 50-65 years old with Type 2 Diabetes Mellitus
- •stable physical condition
- •fasting plasma glucose (FPG) concentration ≥7.8mmol/L or 2-h postprandial blood glucose (PG) ≥11.1mmol/L after 75g oral dextrose with an glycated hemoglobin (HbA1c)>7 %, stable medication.
排除标准
- •pregnancy
- •breastfeeding
- •severe renal or hepatic complications
- •treatment by glucocorticoid
- •having pancreatic disease or malignancy in recent 3 months
- •other factors that may limit adherence to interventions or affect conduct of the trial or participation in another supplementary feeding programme.
结局指标
主要结局
change from baseline in Hb1Ac concentration Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection
时间窗: baseline, 30 days, 6 months and 1 year
Venous blood samples were collected for determination of glycosylated haemoglobin (HbA1c).Changes in outcomes were calculated as values at the end of the intervention period minus those of baseline.
changes from baseline in insulin resistance Hematology index detection Hematology index detection Hematology index detection Hematology index detection Hematology index detection
时间窗: baseline, 30 days, 6 months and 1 year
Venous blood samples were collected for determination of serum insulin.Insulin resistance was measured by HOMO-IR, calculated with the following formula: HOMO-IR=Fasting serum insulin(μU/mL)\*FPG(mmol/L)/22.5
次要结局
- changs from baseline in plasma glucose(baseline, 30 days, 6 months and 1 year)
- changes from baseline in lipid profile(baseline, 30 days, 6 months and 1 year)
- changes from baseline in BMI(baseline, 30 days, 6 months and 1 year)
- changes from baseline in plasma levels of total glutathione peroxidase, malondialdehyde(MDA), superoxide dismutase (SOD), IL-6 and TNF-а(baseline and 30 days)
- changes from baseline in WHR(baseline, 30 days, 6 months and 1 year)
研究者
Yong Li
Professor
Peking University