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NCT04860063 Clinical Trial

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

Metabolic Syndrome Clinical Trial

— BERMESyH  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04860063
Other study ID # MeSHIV-001
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received
Last updated
Start date April 2021
Est. completion date July 2022

Study information
Verified date April 2021
Source Hospital Civil de Guadalajara
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date July 2022
Est. primary completion date April 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Civil de Guadalajara

Outcome
Type Measure Description Time frame Safety issue
Primary Insulin resistance Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months 24 weeks within randomization
Primary Change from baseline lipid profile at 6 months Measurement of total cholesterol, HDL, LDL, triglycerides. At the beginning and 24 weeks within randomization
Secondary Change from baseline weight Weight gain or loss measure by kilograms At the beginning and 24 weeks within randomization
Secondary Inflammatory profile Level of pro-inflammatory cytokines At the beginning and 24 weeks within randomization
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