ISRCTN55835754已完成不适用
Open, controlled clinical study to evaluate the safety of a protein diet (PronoKal method) vs a balanced, low-calorie diet for weight loss in obese diabetic patients.
Pronokal® Group0 个研究点目标入组 90 人开始时间: 2014年11月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
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
- •1. Patients of both sexes aged between the ages of 30 and 65
- •2. Patients diagnosed with type 2 diabetes mellitus with less than 10 years of evolution, non-insulin-
- •dependent1, with pancreatic ß-cell reserve maintained and GAD-negative
- •3. Patients with HbA1c =9
- •4. Patients with a BMI between 30 and 35
- •5. Informed consent (IC) form signed before study participation
排除标准
- •1. Patients over 65 years
- •2. Pregnant or breastfeeding patients
- •3. Patients with severe eating disorders, alcoholism or drug abuse
- •4. Patients with severe psychological disorders (e.g. schizophrenia, bipolar disorder)
- •5. Patients with hepatic impairment
- •6. Patients with renal impairment
- •7. Patients with type 1 diabetes mellitus or insulin-dependent, or currently in treatment with insulin, or candidates for insulin treatment within a short period of time
- •8. Patients with obesity caused by other endocrine diseases (except T2DM)
- •9. Patients with blood disorders
- •10. Cancer patients
- •11. Patients with cardiovascular or cerebrovascular diseases (heart rhythm abnormalities, recent myocardial infarction [<6 months], unstable angina, decompensated heart failure, recent cerebrovascular accident [<6 months])
- •12. Patients with gout
- •13. Patients with kidney stones
- •14. Patients with cholelithiasis
- •15. Patients with depression
- •16. Patients with electrolyte abnormalities
- •17. Patients with orthostatic hypotension
- •18. Patients with an altered or abnormal electrocardiogram
研究者
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