Prevention of type 2 diabetes in HIV: a pilot study of effectiveness and acceptability

Not Applicable

Completed

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

• Registration Number: ISRCTN58156277
• Lead Sponsor: Guy's and St Thomas' NHS Foundation trust (UK)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/30734352/ (added 15/10/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-30
• Study Completion: 2015-08-27
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified