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临床试验/ISRCTN11702341
ISRCTN11702341进行中(未招募)Unknown

The effectiveness of a low-carbohydrate, low-energy diet with remote support for patients with type 2 diabetes in primary care on weight loss: a proof of concept (PoC) trial

niversity of Oxford0 个研究点目标入组 60 人开始时间: 2024年3月19日最近更新:
适应症

试验速览

阶段
Unknown
状态
进行中(未招募)
入组人数
60

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. Participant is willing and able to give informed consent for participation in the study
  • 2. Male or Female, aged 18 – 65 years old
  • 3. BMI equal to or over 27kg/m² (where individuals are from White ethnic groups) or equal to or over 25kg/m2 (where individuals are from Black, Asian and other ethnic groups)
  • 4. Diagnosed with type 2 diabetes
  • 5. Must have good IT skills (they can use a computer/smartphone)
  • 6. Must complete baseline assessments

排除标准

  • 1. Currently diagnosed with type 2 diabetes but who are in remission using the NHS diabetes remission criteria, or who are recorded as not on diabetes medication and whose HbA1c levels on enrolment are <48mmol/mol at baseline
  • 2. Currently using insulin injections
  • 3. GLP1-agonists or SGLT2 inhibitors started in the six months before study enrolment
  • 4. Diagnosed with a known eating disorder for whom the programme could be unsafe or require extensive monitoring to ensure safety
  • 5. People who are pregnant or planning pregnancy
  • 6. People who are breastfeeding
  • 7. Diagnosed with a myocardial infarction or stroke in the past three months, or uncontrolled cardiac conduction abnormalities e.g. long QT syndrome.
  • 8. Currently diagnosed with maculopathy or proliferative retinopathy
  • 9. People with HbA1c =87mmol/mol
  • 10. People with significant life-limiting illnesses that mean that remission is unlikely to improve health (severe cardiac failure, palliatively treated cancer, dementia), or other current severe illness
  • 11. Planned major surgery that means that following a weight loss programme would not be possible.
  • 12. People taking part in other research that would compromise either their participation in eDIAMOND or the other research study/ies that they are participating in.
  • 13. Taking part in or planning to take part in the NHS Pathway to Remission programme.

研究者

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