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Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03976336
Recruitment Status : Recruiting
First Posted : June 6, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
James Backes, PharmD, University of Kansas Medical Center

Brief Summary:
Berberine is a dietary supplement that comes from the roots, stems, and bark of various plants and has been used for centuries in traditional Chinese medicine. It may help lower cholesterol, lower blood sugar, and reduce inflammation.Very few studies have been done in the United States to show how berberine effects cholesterol and blood sugar. This study is looking to see how berberine changes cholesterol and blood sugar, and to see how well it is tolerated.Berberine is not a prescription medication but it appears to have similar actions to common prescription medications to lower cholesterol like statins, and to lower blood sugar like metformin. We are studying berberine to see if it may be a good option for people that do not want to take prescription medications.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Berberine Other: Identical Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Berberine Dietary Supplement: Berberine
500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total

Placebo Comparator: Identical Placebo Other: Identical Placebo
500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total




Primary Outcome Measures :
  1. Change in LDL Cholesterol [ Time Frame: Baseline to week 12 ]
    LDL cholesterol measured by fasting blood sample

  2. Change in Hemoglobin A1c [ Time Frame: Baseline to week 12 ]
    Glucose control as measured by fasting blood sample


Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Week 4, Week 8, and Week 12 ]
    Number of participants with adverse events will be measured by a monthly follow-up questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years and older
  • Current LDL-C of ≥80 mg/dL or higher
  • Current fasting triglyceride level of ≥300 mg/dL
  • 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

  • A male or a non-pregnant female
  • Mentally competent to understand study rationale and protocol
  • Able to speak and read English

Exclusion Criteria:

  • Currently taking any lipid-altering agents including but not limited to statins, niacin (>500 mg), bile-acid sequestrants, ezetimibe, fibrates, and Omega-3 fish/krill oils (>1000 mg EPA/DHA).
  • Prior evidence of a vascular event (e.g. stroke, myocardial infarction, revascularization, peripheral vascular disease)
  • Current use of any oral hypoglycemia agent or parenteral medication for diabetes mellitus (e.g. GLP-1 agonists, insulin)
  • Currently taking any drugs with the potential to interact with berberine, including but not limited to cyclosporine, simvastatin, lovastatin, metformin, saquinavir, darunavir, tacrolimus, sirolimus.
  • Previous history of diabetes mellitus, HbA1c ≥ 6.5%, or FPG > 126 mg/dL
  • Chronic disease involving, hepatic, renal, or coronary heart disease, systemic infection (e.g. HIV) or organ transplantation
  • Currently taking systemic steroidal drugs
  • Dependence on alcohol (> 10 drinks per week) or illicit drugs
  • Pregnant or lactating
  • Participation in any other clinical trial within the last 30 days
  • Presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study
  • Acute or chronic GI conditions (e.g. irritable bowel syndrome, ulcerative colitis)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976336


Contacts
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Contact: Rebecca Study Coordinator 913-588-2762 rmount2@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Rebecca Study Coordinator    913-588-2762    rmount2@kumc.edu   
Principal Investigator: James Backes, PharmD         
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: James Backes, PharmD University of Kansas Medical Center
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Responsible Party: James Backes, PharmD, Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03976336    
Other Study ID Numbers: STUDY00143015
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases