- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049396
Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD) (NAFLD)
August 6, 2019 updated by: Lida Nejati
The Effect of Berberine on Lipid Profile, Liver Enzymes and Fasting Blood Glucose in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD): A Randomized Controlled Trial
Non-alcoholic fatty liver disease (NAFLD), one of the most common liver dysfunctions, affects about one-fourth of the global adult population and has a significant mortality rate between 6.3% and 33%.NAFLD can lead to other serious illnesses.
The disease is associated with a group of metabolic comorbid conditions, including type 2 diabetes mellitus (T2DM), obesity, hypertension, and hyper-cholesterolemia, which are potential risk factors for progressive liver disease.This study sought to evaluate the therapeutic effect of berberine on the liver function and metabolic profiles of patients with NAFLD.
In this context,A six week, open-label randomized controlled trial was conducted in a single medical center at Takestan Hospital, Iran.
A total of 281 patients with NAFLD were enrolled and randomly assigned to treatment arm with (n=24) or without (n=24) berberine.
All patients had received pre-randomization lifestyle training including recommendations on low-fat diet.
Blood examinations were performed to evaluate glucose, lipid profile, and liver enzymes both at the beginning of the study and upon the completion of the trial (day 45).
To assess tolerability of the study intervention and any possible adverse events, patients in both groups were required to attend weekly follow-up visits.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A seven-week (45-day), open-label, randomized controlled trial was conducted in a medical center affiliated with the Ministry of Welfare and Social Security in Iran to study the impact of berberine on liver function and metabolic profiles of patients with NAFLD.
Hospital employees who met the enrollment criteria were identified through electronic health records (EHRs) available in a human resource database of employee routine annual examinations.
Using a computer-generated random-allocation sequence, eligible employees were equally assigned (1:1) to berberine 6.25 g per day (arm A) or no intervention (Arm B).
Berberine was administered orally (100 g dried berberine in 5 Liter water boiled at 167°F until 4Liter).).
To control the potential impact of confounders on outcome measures, and to balance the daily dietary and physical activity among the study groups, all participants were trained by skilled experts on lifestyle and behavior improvement.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 1477893855
- Sciences & Research Branch,Azad University of Tehran
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have an age range between 18 to 65 years(inclusive).
- Patients with Liver fat content assessed by MRS≥13%.
- Patients must meet the criteria for impaired glucose regulation
- Course of diabetic mellitus less than 1 year
- Informed consent signed
Exclusion Criteria:
Any causes of chronic liver disease other than NAFLD(such as-but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, etc.);
- Patients with significantly impaired liver function: ALT or AST≥2 times upper limit of normal;
- Patients with type 1 diabetes mellitus or gestational diabetes or special type diabetes;
- Course of diabetes more than 1 years;
- Diabetics patients who have taken or are taking oral glucose-lowering drugs or insulin;
- Diabetics patients with a HbA1c>7.5% on initial visit;
- Patients with severe diabetes complications(diabetes ketoacidosis, diabetes coma or with symptomatic of diabetes coma; dysfunction of nerve, retinopathy, dysfunction of kidney);
- Patients with a history of clinically significant heart disease(myocardial infarct, heart failure, and/or severe cardiac rhythm);
- Complicating severe infection,within 6 months after operation, severe trauma;
- Patients with excess alcohol consumption≥140g/week(male); ≥70g/week(female);
- Patients have participated other clinical trials within 24 weeks;
- Patients with a history of drug allergy to berberine;
- Patients with gestation or possible gestation or lactation, or males or females expecting gestation during clinical trial;
- Mental diseases patients;
- Those who refuse to sign informed consent;
- Any other conditions, which, in the opinion of the investigators would impede competence or compliance or possibility of hindering completion of the study;
- Patients with serum triglyceride≥5.0mmol/L;
- Patients with thyroid disease, including hyperthyroidism or hypothyroidism.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
No intervention
|
|
Experimental: Berberine
Berberine (6.25 g/day)
|
24 Patient consumed 6,25 g/day Berberine for 6 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of Alanine Aminotransferase (ALT)
Time Frame: Baseline and 6 weeks after
|
Serum Alanine Aminotransferase concentration (units per liter)
|
Baseline and 6 weeks after
|
Change from baseline of Aspartate Aminotransferase (AST)
Time Frame: Baseline and 6 weeks after
|
Serum Aspartate Aminotransferase concentration(units per liter)
|
Baseline and 6 weeks after
|
Change from baseline of Alkaline Phosphatase( ALP)
Time Frame: Baseline and 6 weeks after
|
Serum Alkaline Phosphatase concentration (units per liter)
|
Baseline and 6 weeks after
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline of fasting blood sugar(FBS)
Time Frame: Baseline and 6 weeks after
|
Fasting blood sugar concentration (mg/dl)
|
Baseline and 6 weeks after
|
Change from baseline of total cholesterol (TC)
Time Frame: Baseline and 6 weeks after
|
Serum total cholesterol concentration (mg/dl)
|
Baseline and 6 weeks after
|
Change from baseline of LDL-Cholesterol
Time Frame: Baseline and 6 weeks after
|
Serum LDL-Cholesterol concentration (mg/dl)
|
Baseline and 6 weeks after
|
Change from baseline of HDL - Cholesterol
Time Frame: Baseline and 6 weeks after
|
Serum HDL-Cholesterol concentration (mg/dl)
|
Baseline and 6 weeks after
|
Change from baseline of Triglyceride (TG)
Time Frame: Baseline and 6 weeks after
|
Serum Triglyceride concentration (mg/dl)
|
Baseline and 6 weeks after
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
March 25, 2019
Study Completion (Actual)
June 15, 2019
Study Registration Dates
First Submitted
July 21, 2019
First Submitted That Met QC Criteria
August 6, 2019
First Posted (Actual)
August 8, 2019
Study Record Updates
Last Update Posted (Actual)
August 8, 2019
Last Update Submitted That Met QC Criteria
August 6, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IR.IAU.SRB.REC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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