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

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Brief Title

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

Official Title

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

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.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Insulin resistance

Secondary Outcome

 Change from baseline weight

Condition

Metabolic Syndrome

Intervention

Berberine

Study Arms / Comparison Groups

 Placebo
Description:  Placebo three times daily for 6 months

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

April 2021

Completion Date

July 2022

Primary Completion Date

April 2022

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
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04860063

Organization ID

MeSHIV-001


Responsible Party

Principal Investigator

Study Sponsor

Hospital Civil de Guadalajara


Study Sponsor

, , 


Verification Date

April 2021