CTRI/2019/06/019854已完成1 期
Electrical Vestibular Nerve Stimulation for the Management of Diabetes
eurovalance lab0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
入选标准
- •Type 2 diabetes mellitus or impaired glucose tolerance (also termed pre-diabetes)
- •18-80 years of age inclusive on starting the study.
- •Ability and willingness to complete all study visits and procedures.
- •Owner of a smart phone (iOS or Android) in order to access the diet monitoring and advice app (GB Healthwatch 360), activity monitoring app called Moves, and the app that reports on the status of the stimulation devices used in the study.
- •Agreement not to use of prescription drug therapy or the use of over-the-counter weight loss preparations for the duration of the trial.
- •Agreement not to start smoking tobacco or marijuana for the duration of the study.
- •Access to Wi-Fi connection at home or at workplace â?? so device can upload usage data.
- •Stable diabetic regime for the last 3 months â?? i.e. no change in diabetic medication.
排除标准
- •History of vestibular dysfunction.
- •History of pancreatic surgery.
- •History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears, or of the head and neck.
- •History of weight loss device implantation (e.g. VBloc Maestro or Abiliti).
- •Untreated thyroid disorder (stable treatment for 3 months is acceptable).
- •Other untreated endocrinological disorder that may cause hyperglycemia (e.g. Cushingâ??s disease, Cushingâ??s syndrome or acromegaly) (Stable for 6 months is acceptable)
- •Previous diagnosis of HIV infection or AIDS (HIV is known to cause a vestibular neuropathy, which would prevent VeNS from working).
研究者
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