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Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD) (NAFLD)

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Berberine

About this trial

This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, Berberine, ALP, AST, ALT, FBS, HDL,LDL

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sciences & Research Branch,Azad University of Tehran

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Berberine

Control

Arm Description

Berberine (6.25 g/day)

No intervention

Outcomes

Primary Outcome Measures

Change from baseline of Alanine Aminotransferase (ALT)

Serum Alanine Aminotransferase concentration (units per liter)

Change from baseline of Aspartate Aminotransferase (AST)

Serum Aspartate Aminotransferase concentration(units per liter)

Change from baseline of Alkaline Phosphatase( ALP)

Serum Alkaline Phosphatase concentration (units per liter)

Secondary Outcome Measures

Change from baseline of fasting blood sugar(FBS)

Fasting blood sugar concentration (mg/dl)

Change from baseline of total cholesterol (TC)

Serum total cholesterol concentration (mg/dl)

Change from baseline of LDL-Cholesterol

Serum LDL-Cholesterol concentration (mg/dl)

Change from baseline of HDL - Cholesterol

Serum HDL-Cholesterol concentration (mg/dl)

Change from baseline of Triglyceride (TG)

Serum Triglyceride concentration (mg/dl)

Full Information

NCT ID

NCT04049396

First Posted

July 21, 2019

Last Updated

August 6, 2019

Sponsor

Lida Nejati

1. Study Identification

Unique Protocol Identification Number

NCT04049396

Brief Title

Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD)

Acronym

NAFLD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

October 1, 2018 (Actual)

Primary Completion Date

March 25, 2019 (Actual)

Study Completion Date

June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lida Nejati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Alcoholic Fatty Liver Disease

Keywords

NAFLD, Berberine, ALP, AST, ALT, FBS, HDL,LDL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

In this study , samples were randomly divided into two groups receiving and not receiving supplement

Masking

None (Open Label)

Masking Description

This study was conducted as an open-label, randomized controlled trial .

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Berberine

Arm Type

Experimental

Arm Description

Berberine (6.25 g/day)

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Other

Intervention Name(s)

Berberine

Intervention Description

24 Patient consumed 6,25 g/day Berberine for 6 weeks

Primary Outcome Measure Information:

Title

Change from baseline of Alanine Aminotransferase (ALT)

Description

Serum Alanine Aminotransferase concentration (units per liter)

Time Frame

Baseline and 6 weeks after

Title

Change from baseline of Aspartate Aminotransferase (AST)

Description

Serum Aspartate Aminotransferase concentration(units per liter)

Time Frame

Baseline and 6 weeks after

Title

Change from baseline of Alkaline Phosphatase( ALP)

Description

Serum Alkaline Phosphatase concentration (units per liter)

Time Frame

Baseline and 6 weeks after

Secondary Outcome Measure Information:

Title

Change from baseline of fasting blood sugar(FBS)

Description

Fasting blood sugar concentration (mg/dl)

Time Frame

Baseline and 6 weeks after

Title

Change from baseline of total cholesterol (TC)

Description

Serum total cholesterol concentration (mg/dl)

Time Frame

Baseline and 6 weeks after

Title

Change from baseline of LDL-Cholesterol

Description

Serum LDL-Cholesterol concentration (mg/dl)

Time Frame

Baseline and 6 weeks after

Title

Change from baseline of HDL - Cholesterol

Description

Serum HDL-Cholesterol concentration (mg/dl)

Time Frame

Baseline and 6 weeks after

Title

Change from baseline of Triglyceride (TG)

Description

Serum Triglyceride concentration (mg/dl)

Time Frame

Baseline and 6 weeks after

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Sciences & Research Branch,Azad University of Tehran

City

Tehran

ZIP/Postal Code

1477893855

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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Berberine and Non-Alcoholic Fatty Liver Disease (NAFLD)

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