What side effects are associated with this type of intervention?

Common treatments for Metabolic Syndrome, such as statins and metformin, have known side effects. Statins can cause muscle pain, liver damage, increased blood sugar levels, and digestive issues. Metformin can lead to gastrointestinal problems like nausea, vomiting, diarrhea, and, rarely, lactic acidosis. Both treatments are generally well-tolerated but require monitoring for these side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of metabolic syndrome, particularly targeting dyslipidemia and hyperglycemia. Statins, such as atorvastatin and rosuvastatin, are commonly used to lower cholesterol levels. Metformin is widely used to manage blood sugar levels in patients with type 2 diabetes. These drugs work by mechanisms that reduce cholesterol synthesis and improve insulin sensitivity, respectively. Berberine, a dietary supplement, is being studied for its potential to lower cholesterol and blood sugar through similar mechanisms, making it a promising complementary therapy for metabolic syndrome.

What other types of research exist?

Promising alternatives to Berberine for Metabolic Syndrome patients include GLP-1 receptor agonists (such as liraglutide and semaglutide) and SGLT-2 inhibitors (such as empagliflozin and canagliflozin). These medications have shown efficacy in lowering blood sugar and improving cardiovascular outcomes. Additionally, weight loss interventions, including low-energy diets and bariatric surgery, have demonstrated benefits in improving metabolic parameters and quality of life.

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Dietary Supplement

Berberine for Metabolic Syndrome

N/A

Recruiting

Led By James Backes, PharmD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years and older

Meets current criteria for metabolic syndrome (≥3 of the following): Waist circumference ≥ 35" female or ≥40" for male, Triglycerides ≥ 150 mg/dL, Low HDL-c <40 mg/dL male or <50 mg/dL female, Elevated blood pressure ≥ 130/85 mmHg (or on BP medication), Elevated fasting blood glucose ≥100 mg/dL

Must not have

Previous history of diabetes mellitus, HbA1c ≥ 6.5%, or FPG > 126 mg/dL

Currently taking systemic steroidal drugs

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4, week 8, and week 12

Summary

This trial is studying berberine, a plant-based supplement used in traditional Chinese medicine, to see if it can lower cholesterol and blood sugar. The study targets people who prefer not to use prescription medications. Berberine works in a way similar to some common drugs by managing cholesterol and blood sugar levels. Berberine has been used in traditional Chinese medicine for over a thousand years to treat various conditions, including bacterial infections, diabetes, and cardiovascular diseases.

Who is the study for?

Adults over 18 with metabolic syndrome, characterized by certain waist sizes, triglyceride and HDL cholesterol levels, blood pressure, and fasting blood glucose. They must not be on lipid-altering agents or have conditions like diabetes or chronic GI issues that could interfere with the study.

What is being tested?

The trial is testing Berberine's effects on cholesterol and blood sugar compared to a placebo. It aims to determine if Berberine can be an alternative to prescription medications for lowering cholesterol and blood sugar in people who prefer supplements.

What are the potential side effects?

Potential side effects of Berberine may include digestive upset similar to those experienced with statins or metformin. Since it's being studied as an alternative to these drugs, side effects might also mirror those associated with them.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I meet at least 3 criteria for metabolic syndrome.

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I understand the purpose and plan of the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes with an HbA1c of 6.5% or higher, or my fasting blood sugar is over 126 mg/dL.

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I am currently on steroid medication.

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I have a condition affecting my stomach or intestines, like IBS or ulcerative colitis.

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I have had a stroke, heart attack, or surgery for blood flow problems.

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I am currently taking medication to manage my cholesterol or triglycerides.

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I have a chronic condition like heart, kidney disease, HIV, or had an organ transplant.

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I am currently taking medication for diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4, week 8, and week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4, week 8, and week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 8, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hemoglobin A1c

Change in LDL Cholesterol

Secondary study objectives

Number of participants with adverse events

Side effects data

From 2020 Phase 3 trial • 36 Patients • NCT02548832

25%

Dyspepsia

Headache

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Berberine

Bezafibrate

Berberine Plus Bezafibrate

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BerberineExperimental Treatment1 Intervention

Group II: Identical PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Berberine

2016

Completed Phase 4

~4250

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Metabolic Syndrome include statins, metformin, and lifestyle interventions. Statins work by inhibiting the enzyme HMG-CoA reductase, which reduces cholesterol synthesis in the liver, thereby lowering blood cholesterol levels. Metformin improves insulin sensitivity and reduces glucose production in the liver, helping to lower blood sugar levels. These mechanisms are crucial for Metabolic Syndrome patients as they address key components of the syndrome—dyslipidemia and hyperglycemia—thereby reducing the risk of cardiovascular disease and type 2 diabetes. Berberine, a dietary supplement, has similar actions to statins and metformin, making it a potential alternative for patients seeking non-prescription options.

Meta-analysis of the effect and safety of berberine in the treatment of type 2 diabetes mellitus, hyperlipemia and hypertension.