Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

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

Trial website

Contact information



Primary contact

Mr Alastair Duncan


Contact details

St Thomas's Hospital
249 Westminster Bridge Road
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Prevention of type 2 diabetes in HIV: a pilot study of effectiveness and acceptability: a non-randomised controlled trial


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


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Diabetes Research Network, Infection; Subtopic: Type 2, Infection (all Subtopics); Disease: Diabetic Control, Infectious diseases and microbiology, Education


Lifestyle advice, 6 months of individualised diet and physical activity advice; Follow Up Length: 6 month(s); Study Entry : Registration only

Intervention type



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


Overall trial end date


Reason abandoned


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
2. Health professional working in HIV care

Participant type


Age group




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 participant’s history may change as elements are forgotten.

Part 4:
1. Are unable to attend a single focus group

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

St Thomas's Hospital
United Kingdom

Sponsor information


Guy's and St. Thomas' NHS Foundation trust (UK)

Sponsor details

Asthma Allery & Respiratory science
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

NIHR Doctoral Research Fellowship; Grant Codes: CDRF-2012-03-021

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes