Topic: Diabetes Research Network, Infection
Conditions
Interventions
Lifestyle advice, 6 months of individualised diet and physical activity advice
Sponsors
Guy's and St Thomas' NHS Foundation trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in insulin resistance; Timepoint(s): Measured by frequently sampled liquid meal tolerance test at Day 1 and Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed