ISRCTN28161621进行中（未招募）未知
Ketogenic Diet and Action in Diabetes: evaluation of safety, efficacy and possible mechanisms of action. A 12-month, single-centre, randomized, open, intervention study comparing ketogenic diet versus conventional diet in obese subjects with and without type 2 diabetes
niversity of Palermo0 个研究点目标入组 40 人开始时间: 2018年11月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- 性别
- All
入选标准
- •Group of patients with type 2 diabetes (n=20):
- •1. Patients of both sexes
- •2. Age 18 - 65 years
- •3. BMI 27-39.9 kg/m2
- •4. DT2 known from <6 years
- •5. Glycated hemoglobin = 6.5% and <= 10%
- •Non-diabetic patients (n= 20):
- •1. Patients of both sexes
- •2. Age 18 - 65 years
- •3. BMI 27-39.9 kg/m2
- •4. Glycated hemoglobin <6.5%; fasting blood glucose <126 mg/dl
排除标准
- •1. Chronic ischemic heart disease (acute coronary syndrome, revascularization procedures)
- •2. Heart failure class III-IV NYHA
- •3. Respiratory failure in O2 therapy for COPD, pulmonary fibrosis, bronchial asthma
- •4. Evidence of renal failure stage =G3a NKF (eGFR- CKD-EPI <60 ml/min/1.73 m2)
- •5. Liver cirrhosis
- •6. Type 1 diabetes
- •7. History of neoplastic disease in the last 10 years
- •8. Presence of eating behavior disorders
- •9. Alcohol abuse (>20 g/day for women; >30 g/day for men) and/or drugs
- •10. Severe psychiatric disorders/use of antipsychotic drugs
- •11. Insulin therapy
- •12. Pregnancy or intention of pregnancy
- •13. Participation in other trials
研究者
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