← Back to Search

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
Awards & highlights

Summary

This trial is studying the effects of berberine on cholesterol and blood sugar levels, and how well it is tolerated.

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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
I meet at least 3 criteria for metabolic syndrome.
Select...
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:
Select...
I have diabetes with an HbA1c of 6.5% or higher, or my fasting blood sugar is over 126 mg/dL.
Select...
I am currently on steroid medication.
Select...
I have a condition affecting my stomach or intestines, like IBS or ulcerative colitis.
Select...
I have had a stroke, heart attack, or surgery for blood flow problems.
Select...
I am currently taking medication to manage my cholesterol or triglycerides.
Select...
I have a chronic condition like heart, kidney disease, HIV, or had an organ transplant.
Select...
I am currently taking medication for diabetes.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Hemoglobin A1c
Change in LDL Cholesterol
Secondary outcome measures
Number of participants with adverse events

Side effects data

From 2020 Phase 3 trial • 36 Patients • NCT02548832
25%
Dyspepsia
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bezafibrate
Berberine
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

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.

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
472 Previous Clinical Trials
171,399 Total Patients Enrolled
2 Trials studying Metabolic Syndrome
121 Patients Enrolled for Metabolic Syndrome
James Backes, PharmDPrincipal Investigator - University of Kansas Medical Center
University of Kansas Medical Center

Media Library

Berberine (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT03976336 — N/A
Metabolic Syndrome Research Study Groups: Berberine, Identical Placebo
Metabolic Syndrome Clinical Trial 2023: Berberine Highlights & Side Effects. Trial Name: NCT03976336 — N/A
Berberine (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03976336 — N/A
~1 spots leftby Oct 2024