Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.

Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04860063

Acronym

BERMESyH

Enrollment

Registered

2021-04-26

Start date

2021-04-30

Completion date

2022-07-31

Last updated

2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Glucose Intolerance, HIV-1-infection, Lipoatrophy, Lipodystrophy, Metabolic Syndrome

Brief summary

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.

Interventions

DRUGBerberine

Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months

DRUGPlacebo

Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Age between 18 and 60 years * Documented HIV-1 infection * Stable antiretroviral therapy at least 6 months before enrollment * Viral suppression * Metabolic syndrome , defined by Adult Treatment Panel-III criteria * No previously known kidney or liver disease * Signed informed consent

Exclusion criteria

* People younger than 18 years and older than 60 years * Prior atherosclerotic cardiovascular disease * Diabetes mellitus type 1 or 2 * Previous use of glucose and/or lipid modifying medications * Pregnancy * Withdrawal of informed consent

Design outcomes

Primary

Measure	Time frame	Description
Insulin resistance	24 weeks within randomization	Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months
Change from baseline lipid profile at 6 months	At the beginning and 24 weeks within randomization	Measurement of total cholesterol, HDL, LDL, triglycerides.

Secondary

Measure	Time frame	Description
Change from baseline weight	At the beginning and 24 weeks within randomization	Weight gain or loss measure by kilograms
Inflammatory profile	At the beginning and 24 weeks within randomization	Level of pro-inflammatory cytokines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026