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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 8, and week 12
Awards & highlights
Study 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 belowSelect...
I am 18 years old or older.
Select...
I meet at least 3 criteria for metabolic syndrome.
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I understand the purpose and plan of the study.
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I am a man or a woman not currently pregnant.
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
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 • NCT0254883225%
Dyspepsia
17%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bezafibrate
Berberine Plus Bezafibrate
Berberine
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
~4200
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
459 Previous Clinical Trials
169,064 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your fasting triglyceride level is higher than 300 mg/dL.I have diabetes with an HbA1c of 6.5% or higher, or my fasting blood sugar is over 126 mg/dL.I am 18 years old or older.I am currently on steroid medication.I meet at least 3 criteria for metabolic syndrome.Your current LDL cholesterol level is 80 mg/dL or higher.I understand the purpose and plan of the study.I have a condition affecting my stomach or intestines, like IBS or ulcerative colitis.I have had a stroke, heart attack, or surgery for blood flow problems.I am currently taking medication to manage my cholesterol or triglycerides.I have a chronic condition like heart, kidney disease, HIV, or had an organ transplant.You are addicted to alcohol (drinking more than 10 drinks a week) or illegal drugs.I am not taking medications like cyclosporine, simvastatin, or metformin.I am a man or a woman not currently pregnant.I am currently taking medication for diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Berberine
- Group 2: Identical Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings to join this exploration?
"Affirmative. According to the data on clinicaltrials.gov this medical trial, first posted on August 20th 2019, is actively searching for participants. 40 individuals are required at a single site."
Answered by AI
How many participants has this clinical trial enlisted thus far?
"Affirmative. According to clinicaltrials.gov, this scientific study is currently open for enrollment and was initially posted on August 20th 2019. The last update occurred on May 18th 2022; the research team seeks 40 participants from a single site."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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