ISRCTN62452621已完成未知
A low-carbohydrate, low-energy dietary intervention for patients with type 2 diabetes in primary care: a feasibility study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 33
研究概览
简要总结
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30659044 protocol (added 24/02/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/31709697/ results (added 06/10/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or female, aged 18 years or above
- •3. BMI of =30kg/m2
- •4. Diagnosed with type 2 diabetes
- •5. Patients must have undergone diabetic retinopathy screening within the last 12 months
排除标准
- •1. History of, or features suspicious of, an eating disorder
- •2. Pregnant, breastfeeding, currently undergoing fertility treatment, or planning to become pregnant during the course of the study
- •3. Recent MI or CVA (<3 months)
- •4. Uncontrolled ischaemic heart disease, critical ischaemia, uncontrolled hypertension, uncontrolled cardiac arrhythmia (eg inadequate rate control in AF, inadequate episode control paroxysmal AF), cardiac conduction abnormality (eg long QT syndrome)
- •5. Cardiac failure (Grade II New York Heart Association, and more severe)
- •6. Renal failure (CKD Stage 4 or 5)
- •7. Active treatment for cancer (other than skin cancer treated with curative intent by local treatment only)
- •8. Intercurrent serious infection at time of recruitment
- •9. Diagnosed with a significant psychiatric disorder or substance abuse
- •10. Serious neurological disorder, including epilepsy
- •11. Recently undergone significant surgery (<6 months)
- •12. History of bariatric surgery, including gastric banding
- •13. Are currently using a fasting”/low-energy diet
- •14. Unwilling to consider any dietary changes
- •15. Unable to understand English
- •16. Are currently using insulin therapy, or SGLT2 inhibitors (Glifozins – e.g. empaglifozin, dapaglifozin, canaglifozin)
- •17. Non-proliferative retinopathy level R2 or worse (ie, any level more severe than background” non-proliferative diabetic retinopathy, R1), proliferative diabetic retinopathy, or maculopathy
- •18. HbA1c = 93mmol/mol (10.5%)
- •19. Recruiting physician feels they are inappropriate for recruitment due to any other reason
- •NB: If the patient is taking warfarin, they are not excluded from participating in the study, but will be advised to inform their local monitoring service about their participation, and they may be advised to have additional blood test monitoring of their INR as part of their care.
研究者
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