Metabolic SyndromePhase 3BERMESyHNCT04860063
Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in PLWH.
A Phase 3 study testing Berberine in people with Metabolic Syndrome and HIV-1-infection, run by Hospital Civil de Guadalajara.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Metabolic Syndrome, HIV-1-infection, Glucose Intolerance
- What is being tested?
- Berberine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.
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
- Being tested
- Berberine, Placebo
- Medical subject headings
- Metabolic Syndrome, Glucose Intolerance, Dyslipidemias, Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months
PlaceboDrug
Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo three times daily for 6 months Receives: Drug: Placebo |
| Berberine | Experimental | Berberine 500 mg three times daily for 6 months Receives: Drug: Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance
Change from Baseline insulin resistance determined by Homeostasis Model Assessment index, triglyceride to glucose ratio, at 6 months
Measured: 24 weeks within randomization
Change from baseline lipid profile at 6 months
Measurement of total cholesterol, HDL, LDL, triglycerides.
Measured: At the beginning and 24 weeks within randomization
Secondary outcomes (2)
Change from baseline weight
Weight gain or loss measure by kilograms
Measured: At the beginning and 24 weeks within randomization
Inflammatory profile
Level of pro-inflammatory cytokines
Measured: At the beginning and 24 weeks within randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaúl Ariel Navarro Lara, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860063
- Sponsor's protocol ID
- MeSHIV-001
- Acronym
- BERMESyH
- Status last verified
- Apr 2021
- First submitted
- 17 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37611246
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.
- ClinicalTrials.gov ID
- NCT04860063
- Acronym / sponsor ID
- BERMESyH / MeSHIV-001
- Conditions
- Metabolic Syndrome, HIV-1-infection, Glucose Intolerance, Dyslipidemias, Lipodystrophy, Lipoatrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo three times daily for 6 months |
| Berberine | Experimental | Drug: BerberineBerberine 500 mg three times daily for 6 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerberineParticipants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months | Drug | Berberine |
| PlaceboParticipants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months | Drug | Placebo |
Primary outcome
Insulin resistance
Time frame: 24 weeks within randomization
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
Time frame: At the beginning and 24 weeks within randomization
Measurement of total cholesterol, HDL, LDL, triglycerides.
2 secondary outcomes
Change from baseline weight
Time frame: At the beginning and 24 weeks within randomization
Inflammatory profile
Time frame: At the beginning and 24 weeks within randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 37611246Ruiz-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Berberine in people with Metabolic Syndrome and HIV-1-infection, run by Hospital Civil de Guadalajara.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin resistance (time frame: 24 weeks within randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860063, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.