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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo three times daily for 6 months |
|
| Berberine | Experimental | Berberine 500 mg three times daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline weight | Weight gain or loss measure by kilograms | At the beginning and 24 weeks within randomization |
| Inflammatory profile | Level of pro-inflammatory cytokines |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37611246 | Derived | 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. |
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| Placebo | Drug | Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months |
|
| At the beginning and 24 weeks within randomization |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D018149 | Glucose Intolerance |
| D050171 | Dyslipidemias |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006943 | Hyperglycemia |
| D052439 | Lipid Metabolism Disorders |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D001599 | Berberine |
| ID | Term |
|---|---|
| D001600 | Berberine Alkaloids |
| D044182 | Benzylisoquinolines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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