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

Guy's and St Thomas' NHS Foundation trust (UK)0 个研究点目标入组 28 人开始时间: 2014年1月30日最近更新: 2020年10月26日

试验速览

•1. HIV positive adults aged 18 years
•2. Are competent in English language
•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
•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
•1. HIV positive expert patient or patient representative, or an HIV advocate
•2. Health professional working in HIV care

•1. Unable to attend for a single visit
•2. Type 1 diabetes
•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
•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.
•1. Are unable to attend a single focus group

发起方

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