ISRCTN21335883已完成未知
A randomised controlled trial assessing the impact of a Low Calorie Diet on weight loss in obese patients with type 2 Diabetes Mellitus treated with insulin
Imperial College London (UK)0 个研究点目标入组 90 人开始时间: 2012年10月23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
- 90
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32049634/ results (added 03/06/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 23/07/2015:
- •1. Have BMI >30 kg/m²
- •2. Men or women
- •3. Age 18-70 years
- •4. Are willing and able to give informed consent for participation in the study
- •5. Have been on insulin treatment < 10 years or greater than 10 years with a fasting c-peptide of >600
- •Previous inclusion criteria from 11/09/2014 to 23/07/2015:
- •1. Have BMI >30 kg/m²
- •2. Men or women
- •3. Age 18-70 years
- •4. Are willing and able to give informed consent for participation in the study
- •5. Have been on insulin treatment < 10 years
- •Original inclusion criteria:
- •1. Have BMI >30 kg/m²
- •2. Men or women
- •3. Age 18-70 years
- •4. Are willing and able to give informed consent for participation in the study
- •5. Have been on insulin treatment < 4 years
排除标准
- •Current exclusion criteria as of 23/07/2015:
- •1. Have type 1 diabetes
- •2. Any significant diabetes microvascular complication
- •3. Are unable to provide written informed consent
- •4. Have experienced a cardiovascular disease (CVD) event in the previous 6 months
- •5. Are at stage 4 chronic kidney disease or greater (eGFR <30 mL/min/1.73 m²)
- •6. Have a mental incapacity, unwillingness and/or inability to understand, and be able to complete the mental health questionnaires in the provided language
- •7. Currently pregnant, lactating, or planning pregnancy within the study period
- •8. Have binge eating behaviour (will be assessed by Dutch Eating Behaviour Questionnaire)
- •9. Patient has condition precipitating fluid overload such as heart failure (New York Heart Association grade III-IV) and liver cirrhosis
- •10. Are using medication clinically deemed to affect metabolic rate and weight (e.g. beta blockers, corticosteroids, diuretics, etc)
- •11. Have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, ADHD/ADD, post-traumatic stress disorder, obsessive-compulsive disorder)
- •12. Uncontrolled depression
- •13. Have participated in a weight management drug trial in the previous 3 months
- •14. Difficult to control International Normalising Ratio (INR) within the therapeutic range
- •15. Have uncontrolled epilepsy
- •16. Are known or suspected of substance use
- •17. Are lactose intolerant
- •18. Severe musculoskeletal conditions preventing walking
- •20. Have active gallstone disease or known asymptomatic gallstones
- •21. Clinically assessed hypoglycaemia unawareness
- •22. On ECG evidence of left bundle branch block
- •Previous exclusion criteria from 11/09/2014 to 23/07/2015:
- •1. Have type 1 diabetes
- •2. Any significant diabetes microvascular complication
- •3. Are unable to provide written informed consent
- •4. Have experienced a cardiovascular disease (CVD) event in the previous 6 months
- •5. Are at stage 4 chronic kidney disease or greater (eGFR <30 mL/min/1.73 m²)
- •6. Have a mental incapacity, unwillingness and/or inability to understand, and be able to complete the mental health questionnaires in the provided language
- •7. Currently pregnant, lactating, or planning pregnancy within the study period
- •8. Have binge eating behaviour (will be assessed by Dutch Eating Behaviour Questionnaire)
- •9. Patient has condition precipitating fluid overload such as heart failure (New York Heart Association grade III-IV) and liver cirrhosis
- •10. Are using medication clinically deemed to affect metabolic rate and weight (e.g. beta blockers, corticosteroids, diuretics, etc)
- •11. Have significant psychiatric disorder (e.g. schizophrenia, anxiety, panic disorder, ADHD/ADD, post-traumatic stress disorder, obsessive-compulsive disorder)
- •12. Uncontrolled depression
- •13. Have participated in a weight management drug trial in the previous 3 months
- •14. Are on anticoagulant medication - excluding aspirin or clopidogrel
- •15. Have uncontrolled epilepsy
- •16. Are known or suspected of substance use
- •17. Are lactose intolerant
- •18. Severe musculoskeletal conditions preventing walking
- •20. Have active gallstone disease or known asymptomatic gallstones
- •21. Clinically assessed hypoglycaemia unawareness
- •22. On ECG evidence of left bundle branch block
- •Original exclusion criteria:
- •1. Have type 1 diabetes
- •2. Have any significant diabetes microvascular complication
- •3. Are unable to provide written informed consent
- •4. Have experienced a cardiovascular disease (CVD) event in the previous 6 months
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