Condition category
Infections and Infestations
Date applied
30/01/2014
Date assigned
30/01/2014
Last edited
07/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
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 participant’s 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

Sponsor information

Organisation

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

Sponsor details

Asthma Allery & Respiratory science
London
SE1 7EH
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes