NCT01241695已完成不适用
Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- postprandial blood glucose (iAUC) (0-240 min)
研究概览
简要总结
The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk of malnutrition
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test);
- •HbA1c between 6.5-8.5 % (confirmed in the previous 3 months),
- •capable of using oral nutritional supplementation,
- •on stable and controlled anti-diabetic regime for at least 1 months,
- •use of metformin and/or sulphonylureas as oral anti-diabetic medication,
- •in need of nutritional support because of ≥5% involuntary weight loss in the last 3 months, ≥10% involuntary weight loss in the last 6 months, inadequate nutritional intake causing failure to meet nutritional requirements or at risk of developing malnutrition
排除标准
- •diabetes type 1,
- •participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start
- •patients requiring a fibre free diet,
- •enteral tube feed or parenteral nutrition,
- •concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas,
- •known or suspected intolerance or allergy to any component of the investigational product(s),
- •any acute gastrointestinal disease within 2 weeks prior to study entry,
- •gastrectomy, gastroparesis or other gastric emptying abnormalities,
- •acute sever heart failure (NYHA class 4), liver insufficiency / failure (male: ALAT > 150 U/l; female: ALAT > 120 U/l) or renal failure requiring dialysis,
- •cancer cachexia,
- •galactosaemia, fructosaemia,
- •suspicion of drug abuse, abuse of/addiction to alcohol,
- •pregnant or breast feeding women, or fertile women refusing to use contraceptives,
- •patients with untreated major psychiatric disorder,
- •known HIV positive (safety reasons),
- •patient unable to co-operate adequately
研究组 & 干预措施
Test
Experimental
Diben DRINK (200 ml) / a diabetes-specific oral nutritional supplement
干预措施: Oral nutritional supplement, food for special medical purposes (Dietary Supplement)
Control
Placebo Comparator
Fresubin(R) energy fibre DRINK / an isoenergetic standard oral nutritional supplement
干预措施: Oral nutritional supplement, food for special medical purposes (Dietary Supplement)
结局指标
主要结局
postprandial blood glucose (iAUC) (0-240 min)
时间窗: day 84
postprandial blood glucose (iAUC) (0-240 min)
时间窗: day 42
postprandial blood glucose (iAUC) (0-240 min)
时间窗: day 1
次要结局
- postprandial peak blood glucose (0-240 min)(day 1, day 42, day 84)
- postprandial triglycerides (0-240 min)(day 1, day 42, day 84)
- total cholesterol, HDL-cholesterol, LDL-cholesterol(day 1, day 42, day 84)
- total protein, albumin, prealbumin(day 1, day 42, day 84)
- HbA1c, HOMA-IR index(day 1, day 42, day 84)
- c-peptide(day 1, day 84)
- gastrointestinal tolerance(week 1, week 6, week 12)
- palatability / taste test(week 1, week 6, week 12)
- daily compliance(day 1-84)
研究者
研究点 (1)
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