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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 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.
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I am a man or a woman not currently pregnant.

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 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

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

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
~4 spots leftby Oct 2024