Prevention of type 2 diabetes in HIV: a pilot study of effectiveness and acceptability
| ISRCTN | ISRCTN58156277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58156277 |
| Secondary identifying numbers | 15786 |
- Submission date
- 30/01/2014
- Registration date
- 30/01/2014
- Last edited
- 15/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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 have factors associated with type 2 diabetes studied.
Part 2: In this initial study up to 46 patients with insulin resistance receive 6 months of advice to change diet and physical activity. Change in insulin resistance is measured.
Part 3: Participants are interviewed to assess the acceptability of the intervention, and describe what helps and what hinders lifestyle change.
Part 4: Two focus groups of 6-10 participants 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?
Guy's and St Thomas' Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2013 to August 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
Contact information
Scientific
St Thomas's Hospital
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
| alastair.duncan@gstt.nhs.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Prevention, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prevention of type 2 diabetes in HIV: a pilot study of effectiveness and acceptability: a non-randomised controlled trial |
| Study acronym | STOP Diabetes |
| Study objectives | 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(s) | 13/LO/1543; First MREC approval date 11/11/2013 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 23/12/2013 |
| Completion date | 27/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 162; UK Sample Size: 162 |
| Total final enrolment | 28 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 23/12/2013 |
| Date of final enrolment | 01/07/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 7EH
United Kingdom
Sponsor information
Hospital/treatment centre
Asthma Allery & Respiratory science
London
SE1 7EH
England
United Kingdom
"ROR" |
https://ror.org/00j161312 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2020 | 15/10/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/10/2020: Publication reference and total final enrolment number added.
18/09/2017: No publications found, verifying study status with principal investigator.
