ISRCTN32726656已完成未知
Effect of a new disease-specific enteral formula on metabolic control in type two diabetic patients
umico Research B.V. (The Netherlands)0 个研究点目标入组 140 人开始时间: 2006年12月28日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Type two diabetic patients
- •2. Diagnosis of type two diabetes according to World Health Organisation (WHO) criteria for more than six months
- •3. Aged over 18
- •4. Hospitalised patients, patients in nursing homes or home-care patients
- •5. HbA1c between 6.1% and 10,5% (including 6.1% and 10.5%)
- •6. Body Mass Index (BMI) between 18 kg/m^2 and 35 kg/m^2
- •7. Indication for tube feeding for at least six weeks
- •8. Functioning GastroIntestinal (GI) tract, eligible for tube feeding
- •9. Nutrition via Percutaneous Endoscopic Gastrostomy (PEG) or nasogastric tube
- •10. Willing to comply with the study protocol
- •11. Signed informed consent
排除标准
- •1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation/diarrhoea secondary to neuropathy, diarrhoea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy)
- •2. Concomitant intake of parenteral nutrition or other clinical enteral nutrition
- •3. Significant heart (New York Heart Association [NYHA] class IV), hepatic (transaminase more than three times normal) or renal disease (requiring dialysis)
- •4. Concomitant therapy with acarbose
- •5. Concomitant therapy with systemic glucocorticoids or within two weeks prior to study entry
- •6. Nutrition via any tube that has to be placed into the jejunum
- •7. Galactosaemia
- •8. Alcohol abuse
- •9. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- •10. Participation in other studies within four weeks of study entry
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