Dolutegravir insulin sensitivity study
Research type
Research Study
Full title
An open-label, non-randomized study of the impact on insulin sensitivity, lipid and endocrine profile following treatment with dolutegravir in HIV-negative volunteers
IRAS ID
274870
Contact name
Ruth Bryne
Contact email
Sponsor organisation
Chelsea and Westminster Hospital NHS Foundation Trust
Eudract number
2020-004395-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 17 days
Research summary
Metabolic changes and weight increase commonly occur early in many people living with HIV shortly after antiretoviral tretament initiation is thought to be due in part to a reduction in basal metabolic rate following suppression of plasma viremia, improved appetite, lower inflammatory cytokine effects and a reduction in the rate of protein turnover. The association between insulin resistance and body shape changes and weight gain during therapy has not been established. weight gain in the setting of HIV may not be exclusively related to glucose and/ or fat handling, but may also relate to alterations in endocrine function, therefore we proposed study to investigate changes in insulin resistance, lipid metabolism and complete endocrine profile in subject exposed to dolutegravir to investigate the role all these different factors may potentially have in weight gain recently reported in clinical cohorts.
Primary objective of our study is to quantify the difference in change in insulin sensitivity with the administration of dolutegravir HIV seronegative healthy volunteers. Duration of treatment with dolutegravir will be 4 weeks. It is single centre study conducted in clinical research facility in Chelsea and Westminster NHS Hospital.REC name
London - London Bridge Research Ethics Committee
REC reference
21/LO/0410
Date of REC Opinion
14 Jun 2021
REC opinion
Favourable Opinion