NL-OMON41323已完成不适用
Beneficial effects of caloric and protein restriction on markers of the stress response and postoperative recovery - PROTECT - the Protein and Caloric restriction Trial
RIVM0 个研究点目标入组 315 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 315
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
- 年龄范围
- 18 至 99（—）
入选标准
- •- scheduled for (phase 1a) or undergoing (phase 2a) laparoscopic live kidney nephrectomy
- •- scheduled for (phase 1b, phase 1c, phase 1d, phase 1e) and/or undergoing (phase 2b, phase 1d, phase 1e) laparoscopic bariatric surgery
排除标准
- •Phase 1a (awaiting live kidney donation):
- •- Allergic to any of the ingredients of the diet
- •- Participation in another clinical trial within the last 30 days
- •Phase 1b (awaiting bariatric surgery):
- •- Allergic to any of the ingredients of the diet
- •- Participation in another clinical trial within the last 30 days
- •- BMI < 40
- •- Co-morbidities as in diabetes mellitus
- •- Morbid obesity caused by genetic defects or syndromes
- •Phase 1c (telomere length measurement):
- •- BMI < 40
- •- Co-morbidities as in diabetes mellitus
- •- Morbid obesity caused by genetic defects/syndromes
- •Phase 1d/Phase 1e (validation of telomere lenght measurement and measurement telomerase activity):
- •- BMI < 35
- •- Morbid obesity caused by genetic defects/syndromes
- •Phase 2a (undergoing live kidney donation):
- •- Allergic to any of the ingredients of the diet
- •- Bilateral abnormalities of the renal arteries (origin stenosis)
- •- Previous operations of the kidney(s) or adrenals gland(s)
- •- Radiological abnormalities necessitating an open approach
- •- Perioperative conversion to an open approach
- •- Participation in another clinical trial within the last 30 days
- •- Usage of therapeutic anti-clotting medication
- •Phase 2b (undergoing bariatric surgery):
- •- Allergic to any of the ingredients of the diet
- •- Previous operations of the stomach or duodenum
- •- Any abnormalities necessitating an open approach
- •- Perioperative conversion to an open approach
- •- Participation in another clinical trial within the last 30 days
- •- Liver abnormalities found perioperatively necessitating postponing of surgery
- •- Preoperative risk assessment necessitating nutritional intervention
- •- BMI < 40
- •- Co-morbidity as in diabetes mellitus
- •- Morbid obesity caused by genetic defects or syndromes
- •- Usage of therapeutic anti-clotting medication
研究者
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