Plain English Summary
Background and study aims
The risk of HIV patients developing diabetes has been reported to be up to four times higher compared to those without HIV. Lifestyle modifications can prevent type 2 diabetes in the general population; given the differences in the cause of diabetes in HIV, and potential HIV-specific barriers to lifestyle change, it is important to develop effective methods in this population. Therefore, this study aims to find out an effective lifestyle intervention for treating diabetes in HIV.
Who can participate?
The study is open to people living with HIV registered as patients at Guy's and St Thomas' Hospital in London, UK.
What does the study involve?
Part 1: In this comparison study, 162 participants grouped according to blood glucose levels will have factors associated with type 2 diabetes studied.
Part 2: In this initial study up to 46 patients with insulin resistance will receive 6 months of advice to change diet and physical activity. Change in insulin resistance is measured.
Part 3: Participants will be interviewed to find out the acceptability of the intervention, and describe what helps and what hinders lifestyle change.
Part 4: Two focus groups of 6-10 participants will discuss findings to aid the design of a future large-scale study.
What are the possible benefits and risks of participating?
Participants with pre-diabetes are eligible to take part in a 6-month intervention aiming to reduce their risk of developing diabetes; however, this is an initial study and the degree of potential success is not yet known. Participants in the study will help define risk factors for developing type 2 diabetes.
Where is the study run from?
The study will be carried out at Guy's and St Thomas' Hospital in London, UK.
When is the study starting and how long is it expected to run for?
Recruitment has already commenced and will close in July 2015.
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Mr Alastair Duncan
alastair.duncan@gstt.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Mr Alastair Duncan
ORCID ID
Contact details
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
-
alastair.duncan@gstt.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15786
Study information
Scientific title
Prevention of type 2 diabetes in HIV: a pilot study of effectiveness and acceptability: a non-randomised controlled trial
Acronym
STOP Diabetes
Study hypothesis
1. Can individualised lifestyle advice reduce insulin resistance in HIV patients with pre-diabetes?
2. Is this advice acceptable to participants?
3. Are barriers to lifestyle change HIV-specific?
Ethics approval
13 LO 1543; First MREC approval date 11/11/2013
Study design
Non-randomised; Interventional; Design type: Prevention, Treatment
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Diabetes Research Network, Infection; Subtopic: Type 2, Infection (all Subtopics); Disease: Diabetic Control, Infectious diseases and microbiology, Education
Intervention
Lifestyle advice, 6 months of individualised diet and physical activity advice; Follow Up Length: 6 month(s); Study Entry : Registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Change in insulin resistance; Timepoint(s): Measured by frequently sampled liquid meal tolerance test at Day 1 and Day 180
Secondary outcome measures
1. Blood pressure; Timepoint(s): day 1 and day 180
2. Change in anthropometry; Timepoint(s): day 1 and day 180
3. Change in dietary intake; Timepoint(s): day 1 and day 180
4. Change in lipids; Timepoint(s): day 1 and day 180
5. Change in physical activity; Timepoint(s): day 1 and day 180
6. Quality of life; Timepoint(s): day 1 and day 180
Overall trial start date
23/12/2013
Overall trial end date
27/08/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Part 1:
1. HIV positive adults aged 18 years
2. Are competent in English language
Part 2:
1. HIV positive adults aged 18 years old
2. Stable on current antiretrovirals for last 6 months
3. Unlikely to need to change their antiretrovirals within the next 6 months
4. Have insulin resistance (fasting glucose 5.6 - 6.9 mmol/l)
5. Able to give informed consent
6. Willing and able to participate in an exercise programme
7. Able to attend monthly appointments for 6 months
8. In the opinion of the investigator will be unlikely to have any planned events within the next 6 months that would prevent adherence to a lifestyle change programme
9. Competent in English language
Part 3:
1. Those exiting Part 2 after completing the 6 month intervention
2. Those who withdraw from Part 2 after the initial visit and before completing the 6 month intervention
3. Those who were eligible for Part 2, declined the intervention, but consented to interview
Part 4:
1. HIV positive expert patient or patient representative, or an HIV advocate
or
2. Health professional working in HIV care
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 162; UK Sample Size: 162
Participant exclusion criteria
Part 1:
1. Unable to attend for a single visit
2. Type 1 diabetes
Part 2:
1. Have a clinical diagnosis of type 1 or type 2 diabetes
2. Have a fasting glucose indicative of diabetes (=7.0 mmol /l)
3. Have a random glucose indicative of diabetes (=11.1 mmol/l)
4. Are pregnant, planning for a pregnancy, or lactating
5. Are naive to antiretroviral therapy
6. Have medical problems that may interfere with patient safety
7. Have a current medical condition that makes exercise inadvisable
8. Are fitted with an artificial cardiac pacemaker device
9. Have liver impairment suggested by liver function tests (ALT) within the last year elevated =2.5 times above the upper level of the laboratory reference range
10. Have hepatitis B and/or C coinfection
11. Use medicines that might interfere with glucose homeostasis measures, e.g. corticosteroids, anabolic steroids, testosterone or diabetes medications
Part 3:
1. Are unable to undertake the interview within two weeks of withdrawing/completing, as beyond this time the participants history may change as elements are forgotten.
Part 4:
1. Are unable to attend a single focus group
Recruitment start date
23/12/2013
Recruitment end date
01/07/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Thomas's Hospital
London
SE1 7EH
United Kingdom
Funders
Funder type
Government
Funder name
NIHR Doctoral Research Fellowship; Grant Codes: CDRF-2012-03-021
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary