Exogenous ketosis in diabetes

• Research type

  Research Study

• Full title

  Exogenous oral ketones and insulin sensitivity in Type 2 Diabetes

• IRAS ID

  182698

• Contact name

  David A Holdsworth

• Contact email

  david.holdsworth@dpag.ox.ac.uk

• Sponsor organisation

  T delta S

• Clinicaltrials.gov Identifier

  15/SW/0198, South West - Central Bristol

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  This study aims to answer the question:
  Can a dietary supplement drink containing a ‘ketone’ increase the body’s sensitivity to insulin?
  We know that a central part of the medical condition: ‘Type 2 diabetes’ is that the body’s tissues are less sensitive to insulin. ‘Insulin sensitivity’ is a marker of disease severity. As diabetes worsens the insulin sensitivity falls. The result of this is that glucose remains in the blood stream and fails to enter the cells where it is needed.

  There is early evidence from animal studies and from human studies with athletes that indicates that insulin sensitivity may be increased by supplementing the body’s natural levels of ‘ketone bodies’. Ketone bodies are naturally occurring substances made in healthy livers from fats circulating in the bloodstream. This is a normal process.

  We have access to a special drink which contains a molecule which can rapidly boost the body's circulating ketone concentration from the normal low level to a level that would normally require 3 days of complete fasting to achieve.

  We will compare the insulin sensitivity in 10 participants with type 2 diabetes and 10 normal healthy adults after taking a ketone drink, or a taste and appearance-matched control drink (water with flavourings added).

  There are 2 visits for each participant, so that we can test their insulin sensitivity with both normal and raised ketone levels. The order of which drink they receive is randomly allocated. All participants experience both drinks at the 2 visits. This is therefore a randomised, controlled crossover study.

  Insulin sensitivity is measured by infusing (into the bloodstream : iv) a fixed dose of insulin over 2 hours and measuring the amount of glucose (sugar solution) which must be infused into the bloodstream to maintain a normal blood sugar level.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  15/SW/0198

• Date of REC Opinion

  29 Sep 2015

• REC opinion

  Further Information Favourable Opinion