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

NCT04860063 | Unknown Phase 3

• 1 other identifier: MeSHIV-001
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Insulin resistance

  Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months

  24 weeks within randomization

• Change from baseline lipid profile at 6 months

  Measurement of total cholesterol, HDL, LDL, triglycerides.

  At the beginning and 24 weeks within randomization

Secondary Outcomes (2)

• Change from baseline weight

  At the beginning and 24 weeks within randomization

• Inflammatory profile

  At the beginning and 24 weeks within randomization

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo three times daily for 6 months

Drug: Placebo

Berberine

EXPERIMENTAL

Berberine 500 mg three times daily for 6 months

Drug: Berberine

Interventions

Berberine DRUG

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

Berberine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Related Publications (1)

• Ruiz-Herrera VV, Navarro-Lara SA, Andrade-Villanueva JF, Alvarez-Zavala M, Sanchez-Reyes K, Toscano-Pina M, Mendez-Clemente AS, Martinez-Ayala P, Valle-Rodriguez A, Gonzalez-Hernandez LA. Pilot study on the efficacy and safety of berberine in people with metabolic syndrome and human immunodeficiency virus infection. Int J STD AIDS. 2023 Dec;34(14):1042-1052. doi: 10.1177/09564624231196600. Epub 2023 Aug 23.

  PMID: 37611246 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Glucose Intolerance; Dyslipidemias; Lipodystrophy

Interventions

Berberine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperglycemia; Lipid Metabolism Disorders; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: April 17, 2021
• First Posted: April 26, 2021
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 26, 2021

Record last verified: 2021-04