Prevention of Type 2 Diabetes in HIV - Version 1

• Research type

  Research Study

• Full title

  Prevention of Type 2 Diabetes in HIV: A Pilot Study of Effectiveness and Acceptability.

• IRAS ID

  131302

• Contact name

  Alastair Duncan

• Contact email

  alastair.duncan@gstt.nhs.uk

• Sponsor organisation

  Guy's and St. Thomas' Hospital NHS Foundation Trust

• Research summary

  Background:
  The risk of HIV patients developing type 2 diabetes (DM) has been reported to be up to four times higher compared to matched HIV negative people. Lifestyle interventions can prevent DM in the general population; given the differences in cause of DM in HIV, and potential HIV-specific barriers to lifestyle change, it is important to develop effective interventions in this population.

  Objectives:
  • To characterise factors associated with DM in HIV
  • To determine the effectiveness of a lifestyle intervention for treating Insulin Resistance (IR) in HIV
  • To characterise both the acceptability of the intervention, and enablers and barriers to change
  • To use the findings to design a randomised controlled trial (RCT)

  Design:
  HIV Outpatients will be recruited:
  Part 1: Factors associated with DM in HIV.
  In this cross-sectional study, 162 participants grouped according to blood glucose levels will have factors associated with DM characterised.
  Part 2: The Effectiveness of Diet and Exercise Change in Reducing IR in HIV.
  In this pilot study up to 46 patients with IR will receive 6 months of advice to change diet and physical activity. Change in IR measured by a frequently sampled oral glucose tolerance test will be the primary outcome, with a range of other parameters measured.
  Part 3: The Acceptability of Diet and Exercise Change.
  Participants will be interviewed to investigate acceptability of the intervention, and characterise enablers and barriers to lifestyle change.
  Part 4: Design of a RCT.
  Two focus groups of 6-10 participants will discuss findings to aid design of a RCT.

  Outcomes:
  The effectiveness of using lifestyle interventions for treating IR will be determined, measured specifically by fasting glucose tolerance. The acceptability of these interventions will be characterised and facilitate design of a RCT as well as developing clinical models of care.

• REC name

  London - Bromley Research Ethics Committee

• REC reference

  13/LO/1543

• Date of REC Opinion

  30 Oct 2013

• REC opinion

  Favourable Opinion