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
• Status: Not yet recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

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

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