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

Primary Purpose

Metabolic Syndrome, HIV-1-infection, Glucose Intolerance

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Berberine
Placebo
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Berberine

    Arm Description

    Placebo three times daily for 6 months

    Berberine 500 mg three times daily for 6 months

    Outcomes

    Primary Outcome Measures

    Insulin resistance
    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
    Measurement of total cholesterol, HDL, LDL, triglycerides.

    Secondary Outcome Measures

    Change from baseline weight
    Weight gain or loss measure by kilograms
    Inflammatory profile
    Level of pro-inflammatory cytokines

    Full Information

    First Posted
    April 17, 2021
    Last Updated
    April 22, 2021
    Sponsor
    Hospital Civil de Guadalajara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04860063
    Brief Title
    Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.
    Acronym
    BERMESyH
    Official Title
    Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2021 (Anticipated)
    Primary Completion Date
    April 2022 (Anticipated)
    Study Completion Date
    July 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Civil de Guadalajara

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome, HIV-1-infection, Glucose Intolerance, Dyslipidemias, Lipodystrophy, Lipoatrophy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo three times daily for 6 months
    Arm Title
    Berberine
    Arm Type
    Experimental
    Arm Description
    Berberine 500 mg three times daily for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Berberine
    Intervention Description
    Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months
    Primary Outcome Measure Information:
    Title
    Insulin resistance
    Description
    Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months
    Time Frame
    24 weeks within randomization
    Title
    Change from baseline lipid profile at 6 months
    Description
    Measurement of total cholesterol, HDL, LDL, triglycerides.
    Time Frame
    At the beginning and 24 weeks within randomization
    Secondary Outcome Measure Information:
    Title
    Change from baseline weight
    Description
    Weight gain or loss measure by kilograms
    Time Frame
    At the beginning and 24 weeks within randomization
    Title
    Inflammatory profile
    Description
    Level of pro-inflammatory cytokines
    Time Frame
    At the beginning and 24 weeks within randomization

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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