With current antiretroviral therapy, people living with HIV reach virological suppression faster, which in turn leads to a higher life expectancy. Nevertheless, this improved survival rate is not free of other comorbidities, such as metabolic syndrome, characterized by a decrease in glucose tolerance and an increase in insulin resistance. Berberine is an alkaloid that has proven beneficial effects on both glucose tolerance and insulin resistance, but has not been tested in people living with HIV under virological suppression. We hypothesize that berberine will improve inflammatory markers and metabolic profile in this population without significant interactions nor adverse effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months
Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months
Insulin resistance
Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months
Time frame: 24 weeks within randomization
Change from baseline lipid profile at 6 months
Measurement of total cholesterol, HDL, LDL, triglycerides.
Time frame: At the beginning and 24 weeks within randomization
Change from baseline weight
Weight gain or loss measure by kilograms
Time frame: At the beginning and 24 weeks within randomization
Inflammatory profile
Level of pro-inflammatory cytokines
Time frame: At the beginning and 24 weeks within randomization
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