Clinical trial NCT03976336: Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study
Official title: Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Change in LDL Cholesterol
timeFrame: Baseline to week 12
measure: Change in Hemoglobin A1c
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Week 4, Week 8, and Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: James Backes, PharmD
role: PRINCIPAL_INVESTIGATOR
References: