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

• Sponsor: Hospital Civil de Guadalajara (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04860063
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 15

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome; HIV-1-infection; Glucose Intolerance; Dyslipidemias; Lipodystrophy; Lipoatrophy	Drug: Berberine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Berberine on Metabolic Syndrome, Efficacy and Safety in Combination With Antiretroviral Therapy in People Living With HIV.
• Anticipated Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo three times daily for 6 months	Drug: Placebo; Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months
Experimental: Berberine Berberine 500 mg three times daily for 6 months	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

Outcome Measures

Primary Outcome Measures

1. Insulin resistance [24 weeks within randomization]

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

2. Change from baseline lipid profile at 6 months [At the beginning and 24 weeks within randomization]

   Measurement of total cholesterol, HDL, LDL, triglycerides.

Secondary Outcome Measures

1. Change from baseline weight [At the beginning and 24 weeks within randomization]

   Weight gain or loss measure by kilograms

2. Inflammatory profile [At the beginning and 24 weeks within randomization]

   Level of pro-inflammatory cytokines

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hospital Civil de Guadalajara

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shaúl Ariel Navarro Lara, Resident, Hospital Civil de Guadalajara
• ClinicalTrials.gov Identifier: NCT04860063
• Other Study ID Numbers: MeSHIV-001
• First Posted: Apr 26, 2021
• Last Update Posted: Apr 26, 2021
• Last Verified: Apr 1, 2021

• 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
• Additional relevant MeSH terms: Lipodystrophy; Metabolic Syndrome; Dyslipidemias; Glucose Intolerance; Syndrome

Study Results

No Results Posted as of Apr 26, 2021