This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine in reducing visceral and liver adipose tissue among individuals with obesity and non-alcoholic fatty liver disease (NAFLD) in China.
The trial aims to evaluate the efficacy and safety of berberine treatment for obesity and NAFLD. Potential eligible patients will be recruited from 10-20 medical centers in China. After a 4-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 1.0 g per day plus lifestyle intervention (Arm A) or placebo plus lifestyle intervention (Arm B). The participants will be asked to attend the visit at least once every 2 months, and be followed up for 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
337
berberine hydrochloride 500mg twice a day for 6 months plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.
Placebo with identical shape, colour, odour and taste twice a day plus lifestyle intervention. Lifestyle intervention is based on "Guidelines of prevention and treatment for non-alcoholic fatty liver disease (2018 update)" and "China Blue Paper on Obesity Prevention and Control", including health education on diet, physical activity and weight loss, etc.
Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
Beijing, China
Change of visceral fat content
Measurement of visceral fat by computed tomography
Time frame: 6 months
Change of liver fat content
Measurement of liver fat content by computed tomography
Time frame: 6 months
Change of fasting plasma glucose
Measurement of fasting plasma glucose (FPG)
Time frame: 6 months
Change of HbA1c
Measurement of HbA1c
Time frame: 6 months
Change of 2-hour postprandial blood glucose
Measurement of 2-hour postprandial blood glucose (2hPG)
Time frame: 6 months
Change of homeostatic model assessment-insulin resistance
Homeostatic model assessment-insulin resistance (HOMA-IR)= (fasting insulin (mIU/L) \* FPG (mmol/L)) / 22.5
Time frame: 6 months
Change of homeostasis model assessment-β cell
Homeostatic model assessment (HOMA-β) = (20 x fasting insulin (mIU/L)) / (FPG (mmol/L) - 3.5)
Time frame: 6 months
Change of homeostasis model assessment-insulin sensitivity
Homeostatic model assessment-insulin sensitivity (HOMA-IS)= 1/ HOMA-IR
Time frame: 6 months
Change of serum triglyceride
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Measurement of serum triglyceride (TG)
Time frame: 6 months
Change of high-density lipoprotein cholesterol
Measurement of high-density lipoprotein cholesterol
Time frame: 6 months
Change of low-density lipoprotein cholesterol
Measurement of low-density lipoprotein cholesterol
Time frame: 6 months
Change of total cholesterol
Measurement of total cholesterol
Time frame: 6 months
Change of lipoprotein (a)
Measurement of lipoprotein (a)
Time frame: 6 months
Change of apolipoprotein
Measurement of apolipoprotein
Time frame: 6 months
Normalization of glucose parameters among participants with prediabetes
Meeting all three criteria: 1) FPG\<6.1 mmol/L; 2) 2hPG\<7.8 mmol/L; 3) HbA1c\<5.7%
Time frame: 6 months
Change of metabolic syndrome z-score
Metabolic syndrome z-score calculated by the five components, including waist circumference, HDL-C, blood pressure, TG and FPG. Higher score indicates greater severity of metabolic syndrome
Time frame: 6 months
Change of visceral fat index
Visceral fat index calculated by waist circumference, body mass index, TG, HDL-C. Higher index indicates higher content of visceral fat
Time frame: 6 months
Change of fat liver index
Fat liver index (FLI) calculated by TG, body mass index, gamma-glutamyltransferase (γ-GGT), waist circumference. Higher index indicates higher content of liver fat
Time frame: 6 months
Change of triglyceride glucose index
Triglyceride glucose index (TyG) calculated by TG and FPG. Higher index indicates higher insulin resistance
Time frame: 6 months
Change of serum urine acid
Measurement of serum urine acid
Time frame: 6 months
Change of serum homocysteine
Measurement of serum homocysteine
Time frame: 6 months
Change of body weight
Measurement of body weight in kg
Time frame: 6 months
Change of body mass index
Weight and height will be combined to report BMI in kg/m\^2
Time frame: 6 months
Change of waist circumference
Measurement of waist circumference in cm
Time frame: 6 months
Change of waist-hip ratio
Waist circumference and hip circumference will be combined to report waist-hip ratio.
Time frame: 6 months
Change of waist-height ratio
Waist circumference and height will be combined to report waist-height ratio.
Time frame: 6 months
Change of systolic blood pressure
Measurement of systolic blood pressure (SBP)
Time frame: 6 months
Change of diastolic blood pressure
Measurement of diastolic blood pressure (DBP)
Time frame: 6 months